FDA-CDRH NCIt Subsets
FDA-CDRH NCIt Subsets
FDA-CDRH NCIt Subsets
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
740
741
3034
554
742
422
743
3035
745
746
736
423
747
748
3036
3037
749
750
424
555
752
556
425
753
3038
3039
754
426
755
756
427
3040
757
758
759
428
429
760
761
762
763
557
3041
3042
558
559
560
435
3043
764
436
765
766
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
3044
768
769
770
3045
771
772
3046
437
561
438
773
562
563
774
775
776
439
777
3047
440
441
778
779
780
442
443
781
782
3048
783
784
785
786
787
3049
788
3050
3051
789
445
790
447
448
791
416
792
793
794
795
796
797
798
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
450
449
452
3052
451
3053
3054
3055
799
800
801
802
3056
454
803
804
455
805
806
3057
807
808
456
809
810
811
812
813
814
3058
3059
3060
3061
815
3062
3063
816
457
817
458
818
819
459
820
460
3064
564
821
822
3065
461
823
462
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
565
825
826
827
828
829
463
3066
3067
3068
830
3069
464
831
832
833
465
466
834
835
836
467
566
567
3070
3071
837
838
468
3072
3073
839
469
470
471
3074
3075
474
472
840
841
842
843
844
845
3076
473
846
847
569
848
849
3077
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
850
851
852
853
1028
854
855
856
857
475
858
859
860
3156
861
862
863
864
865
3078
1030
3079
476
3080
3081
3082
477
866
478
867
868
479
869
870
3083
571
3084
480
572
481
871
482
872
873
874
875
483
876
3085
484
877
573
879
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
880
881
882
883
884
885
886
485
3086
486
3087
574
887
888
889
3088
890
1023
3092
3093
891
487
892
488
3094
894
893
546
895
896
897
898
899
575
490
491
900
3095
901
492
902
903
3096
904
905
493
906
3097
576
577
578
494
907
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
908
579
3098
910
911
495
912
496
497
580
913
498
499
914
915
916
500
581
501
917
918
3099
919
920
503
504
921
922
923
924
925
3157
926
927
505
3100
928
929
930
3101
507
931
582
932
508
933
934
935
937
938
583
939
941
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
942
943
944
945
946
509
947
984
949
948
950
951
952
953
568
3102
3103
954
432
584
3104
510
551
955
956
957
958
3105
3106
959
960
3107
961
962
963
964
965
967
966
511
512
968
969
970
971
972
3108
514
973
974
975
3109
976
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
977
3110
3111
515
516
978
517
3112
979
980
518
981
982
983
3113
3114
3154
519
985
986
987
3115
3116
3117
3118
989
990
991
520
992
993
994
995
996
3119
3120
997
585
998
3121
999
1000
547
3158
3159
3122
3135
3136
3123
586
3124
3125
3137
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
C54577
3138
522
523
524
3139
3140
3141
3142
3143
3144
3145
3126
525
587
3146
3127
444
527
3155
529
530
589
531
532
533
534
535
536
537
538
539
540
541
542
543
3147
588
3148
3149
1018
3150
3128
3151
3129
3195
3130
3131
3132
3152
430
544
3153
545
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91802
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91867
C91868
C91869
C91870
C91871
C91872
C91876
C91882
C91883
C91886
C91887
C91888
C54030
C91873
C91874
C91875
C91877
C91878
C91879
C91880
C91881
C91890
C91891
C91892
C91884
C91885
C91893
C91889
C91894
C91895
C91898
C91899
C91896
C91897
C91900
C91901
C102867
C91902
C91903
C91904
C91905
C91906
C91907
C91997
C91998
C91908
C91909
C91910
C91911
C91912
C91913
C91914
C91915
10
11
12
13
70
50
14
15
92
94
16
63
17
18
19
20
21
22
57
51
23
71
75
24
77
25
26
27
67
61
3261
3262
10
3263
3264
3265
3372
3266
3267
3268
3269
3270
3271
3273
3272
3274
3275
28
3276
3277
3278
3279
3280
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
C91800
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C50859
C50543
C50541
C50544
C50545
C50542
C26759
C50547
C50489
C3348
C26760
C26920
C34582
C34586
C50480
C50443
C50550
C26901
C50841
C50693
C50553
C50856
C48198
C50556
C50819
C34602
C26769
C50857
C50558
C50559
C3036
C50560
C50563
C3038
C50566
C3044
C50532
C76130
C3045
C50568
C50569
C34548
C50524
C50609
C34620
C50444
C50572
C3046
C27783
C50529
C26794
C50745
C50777
1824
1817
2554
1827
2196
1826
1829
1830
1831
1832
2429
1833
1834
1835
1838
1750
1839
1840
2398
2399
2628
1841
1842
1843
2402
1845
1846
1847
1848
2375
1849
1850
1856
1858
1860
3167
2239
2685
1862
1864
1865
2686
2430
2431
2687
1868
1869
1870
2351
2369
2349
2077
2428
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
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FDA
FDA
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FDA
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FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
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FDA
C54450
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C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C14209
C50573
C26780
C26782
C3064
C52352
C50575
C50806
C34660
C34661
C50643
C50601
C50576
C35731
C50577
C34670
C50578
C50579
C3090
C50580
C37965
C34376
C3094
C26791
C50485
C50555
C50896
C50757
C50759
C50761
C50581
C50582
C3095
C34685
C50583
C37966
C14219
C50586
C3109
C3111
C27088
C50588
C26797
C37970
C3113
C3114
C3117
C50589
C50590
C50591
C50592
C50445
C50463
1872
1873
1874
1875
1876
2152
1877
2227
1879
1880
2186
2378
1881
1882
2206
1883
2666
1884
2558
1288
1886
2279
1887
1888
1889
1890
1892
1893
1894
2603
1895
1896
1897
2240
1898
1899
2197
1297
2153
3272
1903
1904
1905
2242
1906
1907
1908
1909
1910
2664
1911
2352
2353
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
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C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C50571
C3126
C50593
C3128
C50523
C50594
C50595
C3890
C50564
C50598
C50599
C3131
C50603
C3133
C50914
C50607
C3429
C73503
C50486
C26726
C2890
C50534
C3245
C50612
C50617
C50719
C50758
C35650
C50791
C3439
C25754
C3137
C3671
C50796
C34818
C50616
C50438
C50618
C50786
C50619
C50621
C50623
C50624
C34738
C50625
C3344
C3143
C26750
C35760
C50627
C26805
C50450
C50917
2354
1912
1913
1914
1915
1916
2243
1918
2210
2498
1923
2156
1924
1925
2646
1927
1928
2065
1771
1930
1735
2244
2419
2245
1933
2246
2247
2420
2120
2248
1931
1932
2348
1926
2665
1333
1891
1937
1936
2662
1940
2421
1941
1942
2493
1943
2187
2374
2373
2356
1944
1945
2465
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C50446
C61390
C61392
C50629
C50630
C50631
C50412
C50633
C50909
C50853
C50634
C50854
C50635
C50636
C50641
C50644
C27153
C3208
C3832
C50431
C50645
C2867
C26828
C35219
C50549
C50792
C34336
C50432
C50429
C48655
C50888
C50653
C50852
C50654
C50655
C75568
C50656
C50657
C50658
C50659
C50660
C27009
C50661
C27996
C34831
C50662
C3258
C16897
C50567
C50665
C50666
C50667
C50668
1946
3161
3162
1947
1948
1949
2560
1952
2671
1953
1954
1955
2418
2562
2501
2397
1956
3263
2359
2370
2198
1958
2389
1959
2232
1871
1962
2159
2561
3192
1963
2512
1964
1965
2471
3261
1966
1412
1967
1968
2161
2238
1763
1969
2470
2466
1970
1971
1972
2462
1974
1975
1976
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
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C54450
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C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C16900
C50669
C50915
C50787
C4974
C50672
C4731
C50673
C50674
C64343
C50675
C53269
C76143
C50912
C50405
C48660
C34857
C3284
C50678
C50849
C50475
C50679
C50680
C50681
C50910
C50873
C50850
C50683
C50504
C50584
C50640
C3303
C50605
C26682
C50663
C50685
C37999
C50686
C3310
C50687
C50688
C61389
C54027
C50525
C50610
C50691
C3889
C4080
C3319
C73501
C35136
C50695
C26849
1978
1979
2647
1980
2689
1982
1983
2162
2441
3191
2199
3190
2692
2645
2250
3189
2415
2422
1984
1986
2106
1987
1428
2377
2651
1988
1990
1991
2234
2478
2477
1994
2388
1685
2433
2468
2467
1447
1997
2448
1998
3166
2688
2435
2436
1999
2000
2001
3271
1852
2002
2003
2252
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
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FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
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C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C27061
C26851
C38003
C50697
C50698
C50548
C17000
C3331
C3333
C38006
C50699
C50700
C26925
C50701
C25742
C34945
C50706
C36173
C50711
C27298
C50585
C50642
C50677
C50712
C26868
C50713
C50714
C51447
C50848
C50715
C50533
C50622
C50716
C50717
C50721
C61395
C50722
C61401
C50862
C50723
C52354
C3349
C50637
C39594
C50724
C25637
C3508
C50419
C50725
C50726
C50797
C50820
C9439
2362
2367
2004
2164
2165
2327
2009
2010
2011
2012
2013
2604
1992
2015
3193
1819
2326
2475
2605
2620
2480
2479
2481
2019
2020
1498
2021
2022
2023
2024
2606
2469
2026
1812
2449
3163
1755
3164
1510
2256
2166
2255
2032
2033
2034
2414
2442
2035
2038
2259
2335
2403
2039
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C4376
C50727
C50728
C50729
C27165
C27560
C26872
C50474
C50767
C50731
C34979
C50732
C34882
C50733
C50846
C50734
C9445
C50827
C50737
C34483
C26746
C76131
C21097
C2962
C50436
C50689
C50847
C50574
C3364
C50739
C38038
C35016
C50452
C50460
C50482
C50596
C50615
C50671
C50703
C35018
C35019
C50782
C50741
C26883
C3327
C50845
C2983
C50743
C50744
C3376
C50746
C50747
C50750
2041
1985
2482
2483
2045
2046
2484
2485
2486
2048
2049
2050
2053
2054
2055
2056
2208
2358
2060
2061
2062
2694
2368
2063
2261
2260
2064
2168
2067
2069
2515
2072
1693
1703
2262
1917
2264
2265
2266
2068
2267
2268
2277
2073
2074
2075
2443
2076
2516
2517
2251
2396
2432
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C50751
C35035
C41330
C50540
C50752
C50921
C50754
C50664
C50756
C50911
C50762
C50763
C50868
C36172
C3399
C50764
C50765
C35053
C50766
C38029
C50552
C50778
C50844
C50916
C36292
C50789
C50526
C50611
C76132
C28195
C26891
C27083
C50770
C50771
C50772
C61375
C50773
C50779
C50780
C35498
C27990
C50493
C50454
C50503
C50781
C50842
C50843
C50783
C50784
C50785
C50794
C3426
C25757
2081
2083
2487
2059
1593
2058
2263
2434
2084
2510
2088
2089
2497
2444
2091
2092
2093
1610
2094
2095
2235
2427
2097
2273
2695
2099
2271
2272
2696
2654
2100
2101
2102
2171
2103
2681
2104
2107
2207
2108
2333
2098
2269
2270
2109
2111
2112
2113
2114
2172
2115
2274
2116
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C54450
C50428
C34851
C26906
C50790
C3432
C50793
C26909
C50795
C50522
C62433
C50600
C40866
C40867
C50798
C3365
C28221
C50430
C50448
C50799
C50800
C50802
C38057
C50647
C50804
C14283
C50602
C50638
C50805
C50837
C50808
C50469
C50639
C50807
C50587
C3442
C50809
C50810
C50811
C50863
C50704
C50705
C50435
C72898
2542
2188
2275
2119
2278
2121
2122
2123
2124
2697
2572
2126
2127
2661
2071
2129
2395
2078
2130
2131
2132
2134
1204
2135
2136
2138
2139
2140
2643
1866
2143
2142
2445
2181
2144
2145
2607
2241
1154
2446
2447
2613
2698
FDA Source PT
FDA Source Synonym(s)
FDA Source Definition
Constipation
Diagnostic, Therapeutic, Or Research Equipment
Noise, Audible
Acoustic Noise|Audible Noise| ISSUE ASSOCIATED WITH
Absorber
Absorber (CO2)
Accumulator
Actuator
Adapter (Adaptor)
Adhesive
Air Cleaner
Air Eliminator
Air Pump Assembly
Alarm
Alarm, Assembly
Alarm, Audible
Alarm, High Inspiratory Pressure
Alarm, LED
Alarm, Low Inspiratory Pressure
Alarm, Oxygen Pressure
Alarm, Power
Alarm, Pressure
Alarm, Self
Alarm, Visual
Alarm, Volume
Alternator
Altimeter
Amplifier
Analyzer
Annunciator
Antenna
Applicator
Arrester
Attenuator
Automatic Injection System
Backpanel
Backplane
Bacterial Filter
Baffle
Bags
Ball
Ballast
Balloon
Barrier
Battery
Battery Charger
Beam Splitter
Bearings
Bed, Assist Bar
Bell
Belt
Blower
Bobbin
Bolometer
Bolt
Bolus Mechanism
Bottom Dead Center Sensor Bracket
Brake
Breathing Circuit
Brush
Bubble Detector
Bus
Bushing
Buzzer
Cable
Calibrator
Camera
Cannula
Cannula Guide
Cannula, Inner
Cannula, Outer
Cap
Capacitor
Carrier
Cascade
Cassette
Caster
Catheter
Cautery
Cell
Charger
Chassis
Choke
Circuit Board
Circuit Breaker
Clamp
Clip
Clock
CO2 Monitor
CO2 Monitor Subassembly (Only Use When Part Of Another Device)
Coder
Coil
Collimator
Comparator
Compressor (Air Pump)
Computer Hardware
Concentrate
Concentrator
Conductor Coil
Connecting Rod
Connector
Connector Pin
Contact Lens
Control Switches
Controller
Converter
Cooling Module
Cooling System
Cord
Core
Counter
Counterbalance
Coupler
Cover
CPU (Central Processing Unit Of Computer System)
CPU (Central Processing Unit) Board
Crank Arm Assembly
CRT (Cathode Ray Tube)
Crystal
Cuff
Cup Seal
Cups
Current Limiter
Current Source
Cusp
Cutter
Cutter-Torque Cable
Cylinder
Cylinder Valve
Damper
Data Acquisition Unit
Decoder
Defibrillator Paddles
Defibrillator Subassembly (Only Use When Part Of Another Device)
Dehumidifier
Dehydrator
Deionizer
Delay Line
Demagnetizer
Demodulator
Densitometer
Detector
Device Component Or Accessory
Device Deployer
Device Ingredient Or Reagent
Device Subassembly
Dial
Diaphragm
Digitizer
Diode
Discrete Component/Device (Resistor, Capacitor, Diode)
Disk
Display
Divider
Dome
Doubler
Driver
Duct
Dummy Load
Duplexer
EKG/ECG Monitor
EKG/ECG Subassembly (Only Use When Part Of Another Device)
Electrical Lead
Electrical Wire
Electrode
Electrode Contact
Emergency Stop Button Or Switch
Emergency Table Stop
Emitter
Enclosure
Encoder
Endoscope
Endoscopic Accessory
EPROM (Erasable Programmable Read Only Memory)
Equalizer
Evaporator
Exhalation Filter
Expander
Extender
External Fiberoptic
Extractor
Eyelet
Fail-Safe System
Fan
Fastener
Feedthru
Ferrule
FET (Field Effect Transistor)
Fiber
Fiberguide
Fiberoptic
Fiberoptic Cladding
Fiberoptic Cleaver
Film
Film Cartridge
Film Processor
Filter
Flange
Flasher
Flowmeter
Foil
Foot Pedal
Foot Switch
Frame
Function Indicator
Function Indicator Light
Function Lid
Furnace
Fuse
Gas Delivery System
Gas Scavenging
Gasket
Gauges/Meters
Meter
Gears
Gear
Generator
Grille
Grommet
Ground Strap
Guide
Guidewire
Hand Immobilizer
Handpiece
Handrest
Handset
Haptic
Header
Headphone
Heads
Headset
Heart Valve Cage
Heart Valve Leaflet
Heart Valve Sewing Ring
Heat Exchanger
Heat Sink
Heater
Heater Rod
Helifix Coil
Hemo Valve
Hermetic Seal
Hinge
Holder
Hollow Fiber
Hose
Hose Line
Housing
Hub
Humidifier
Hybrid Circuit
Hydraulic Bed System
Hydraulic System
IC (Integrated Circuit)
IC (Integrated Circuit) Chip
Igniter
Imager
Impedance Converter
Indexer
Indicator
Inductor
Injection System
Injector System
Insulation
Integrator
Intercom
Interconnection Board Intubate
Interface
Interrupter
Intravenous Pole
Inverter
IOL (Intraocular Lens) Implant
Isolator
Jack
Jaw
Joint
Joystick
Jumper
Junction
Keyboard
Keyer
Keypad
Kit
Knife
Knob
Label
Laminate
Lamp
Laser
Laser Nozzle
Latch
Lead
Lead Conductor
Lead Tip
Leaflet
Leaflet Disk
LED (Light Emitting Diode)
Lenses
Limit Switch
Limiter
Line Conditioner
Lithium Iodide Battery
Load
Lock
Locking Mechanism
Locking Sleeve
Lockout Mechanism
Logic Board
Lower Piston Bearing
Luer Valve
Magazine
Magnet
Magnetizer
Magnetometer
Magnetoresistor
Magnifier
Manifold
Matrices
Mechanism
Membrane
Memory
Meter Needle
Microcircuit
Microphone
Microscope
Mirror
Mixer
Modem
Modulator
Monitor
Motherboard
Motion Detector
Motor
Motor Drive Unit
Motor Roll Pin
Mount
Multiplier
Nebulizer (Only Use When Part Of Another Device)
Needle
Network
None
Nozzle
Nozzle Tip
Nuts
O2 Monitor Subassembly (Only Use When Part Of Another Device)
O2 Sensor
Obturator
One-Way Valve
Optical Cable
Optical Disk
Optical Fiber
Optocoupler
Oscillator
Oscilloscope
Outlet
Oven
Overlay
Oximeter (Only Use When PartOximeter
Oxygen Analyzer
Pad
Pallet
Panel
PC (Printed Circuit) Board
Photodetector
Photomultiplier
Photomultiplier (PM) Tube
Phototransistor
Pickup
Pilot Balloon Valve
Pin
Pipette
Piston Guides
Piston Heads
Piston Pads
Pivot
Plate
Plotter
Plug
Plunger
Pointer
Polarizer
Port
Post
Potentiometer
Power Cord
Power Lamp
Power Module
Power Supply
Power Switch
Preamplifier
Prescaler
Preselector
Pressure Sensor
Pressure Signal
Pressure Tubing
Printer
Probe
Probe, Transducer Pressure
Processor
Programmer
PROM (Programmable Read Only Memory)
Prong
Protector
Proximity Switch
Pulley
Pulser
Pump
Pusher
Pyrometer
Rail
RAM (Random Access Memory)
Rate Modulated Pacing Sensor
Reactor
Reader
Receiver
Receiver Stimulator Unit
Recorder (Tape, Stripchart, Etc.)
Rectifier
Reed (Electrically Open)
Regulator
Relay
Repeater
Reservoir
Resistor
Resonator
Retainer
Retaining Pin
Reticle
Rheostat
Ribbon
Ring
Rivet
Robot
Rod
ROM (Read Only Memory)
Safety Interlock
SAW (Surface Acoustic Wave Device)
Scale
Scaler
Scanner
Scintillometer
Scrambler
Screen
Screw
Screw Head
Screw Tapper
Scriber
Seal
Seal Tracheal
Sediment Filter
Sensor
Servo
Shaft
Shield
Shift Register
Shifter
Shock Capacitor
Shoulder Support
Shunt
Shutter
Side Rail
Signal Conditioner
Simulator
Slide
Slip Ring
Slotter Line
Socket
Socket Adaptor
Solder Joint
Solenoid
Sound Absorber
Spacer
Spark Gap
Speaker
Spectrometer
Speech Processor
Spirometer
Splicer
Spooler
Spring
Spring Loading Mechanism
Stabilizer
Stand
Staple
Steering Wire
Stent
Stepper Motor
Stiffener
Stopcock
Stopcock Valve
Strain Relief
Strip Line
Stylet
Substrate
Sunlamp
Suppressor
Surgical Graft
Suture
Switch, Push Button
Switches
Synchronizer
Synthesizer
Syringe
Syringe Drive
System
Table
Table Top
Tachometer
Tape
Tee
Telemetry Equipment
Telephone
Teleprinter
Teletypewriter
Television Unit
Temperature Compensator
Temperature Probe
Temperature Sensor
Terminal
Terminal Assembly
Terminator
Test Strip
Thermistor
Thermocouple
Thermocouple Wire
Thermometer
Thermostat
Thread
Thyristor
Timer
Tip
Tip Conductor Coil
Tomographic Pallet
T-Piece Connector
Trackball
Transceiver
Transducer
Transformer
Transistor
Translator
Transmission Line
Transmitter
Transponder
Transport
Triac
Three Terminal Current Controlling Semiconductor
Trimmer
Trocar
Tube
Tube Capillary
Tuner
Unit
User Interface
Valve
Valve (One-Way, Hemo, Stopcock, Etc.)
Valve Cam
Valve, Control
Valve, Directional
Valve, Dump
Valve, Exhalation
Valve, Flap
Valve, Flow
Valve, Inhalation
Valve, Inlet Port
Valve, Inspiratory
Valve, Outlet Port
Valve, PEEP (Positive End Expiratory Pressure)
Valve, Pressure Limit
Valve, Relief
Valve, Safety
Valve, Selector
Vaporizer
Varistor
VDT (Video Display Terminal)
Vibrator
Viewer
Voltmeter
Washer
Water Purification System
Waveguide
Wedge Filter
Weld
Wheel
Wheelchair, Tires
Wheelchair, Wheels
Window
Wire
Wiring Harness
Yoke
Y-Piece Connector
Degradation/Corrosion/Erosion Testing
Testing the device for its corrosive behavior to specific enviro
Design Validation
Validating that the device meets the user's needs and intend
Device From Controlled Or Non-Released Sample Evaluated
Device From Reserve Sample Evaluated
Device From Same Lot Evaluated
Device Structure Testing
Testing devices for problems related to the presence of an i
Device-To-Device Interaction Testing
Tests conducted to assess the mechanical, electrical, or elect
Device-To-Human Interaction Testing
Tests conducted to assess the interaction between a device
Elasticity Testing
Testing the device's ability to recover its size and shape afte
Electrical Evaluation
Electrical Fast Burst Testing
Testing the device for failures related to interference voltage
Electrical Slow Fluctuation Testing
Testing the device to detect malfunctions caused by a sudden re
Electromagnetic Compatibility (EMC) Evaluation
Evaluating a device to detect malfunctions caused by electrom
Electron Microscopy
Inspection of objects or surfaces requiring magnification usi
Electrostatic Discharge Testing
Testing the device for malfunctions related to the transfer of a
Emissions Testing
Testing the device for adequately controlled electromagnetic
Environment Evaluation
Evaluating devices for responses to physical characteristics i
Evaluation Method
Fatigue Testing
Testing the device's capability to withstand the progressive a
Flow Testing
Testing the device to assess the volume of fluid moving per uni
Fluid Pressure Testing
Testing the fluid pressure (pressure at some point within a flui
Fracture Toughness Testing
Testing the device's ability to resist local separation into two
Genotoxic Testing
Testing the device's ability to cause damage to genetic materi
Gradient-Induced Field Effect Testing
Testing the RF shield around the coils of an MRI device for its
Growth Factor Evaluation
Evaluating a device's characteristics that may affect the self
Hardness Testing
Testing the device's ability to resist deformation. Hardness is
Hematologic Testing
Testing the device for its affect or impact on the blood or its
Humidity Testing
Testing the device's protective materials to prevent moisture
Image Artifact Testing
Testing an imaging device to determine the amount of distortio
Image Inspection
Macroscopic inspection commonly used to describe physical
Immunity Testing
Testing the device for adequate immunity or capability to resi
Impact Testing
Testing the device's response to a suddenly applied stress. The
Impedance Testing
Testing the resistance to current flow in a device's circuit or
In Situ Observation
Observing the device in the exact same conditions and settin
Infrasound Testing
Ingress Protection Testing
Testing the device's ability to protect against ingress or acces
Installation Review
Performing a review of the processes used to install a device
Insulation Testing
Testing the ability of a device's or component's material to resi
Interference Substance Testing
A test used with in vitro diagnostic analytic systems to detect
Interoperability Evaluation
Testing devices for problems with the mechanical, electrica
Ionizing Radiation Testing
Testing that ionizing radiation is delivered at the appropriat
Labeling Evaluation
Reviewing all labeling (including instructions for use, manua
Light Source Performance Evaluation
Testing the optical properties of a device such as diopter, glar
Light Testing
Testing the device's characteristics when subjected to variatio
Line Voltage Testing
Tests to determine whether a device's insulation has the stre
Magnetically-Induced Displacement Force Testing
Testing the static magnetic field gradients on medical imaging
Magnetically-Induced Torque Testing
Testing the static magnetic field gradients on medical imaging d
Maintenance Review
Performing a review the technical and corresponding administr
Manufacturing Review
Performing a review of the manufacturing steps and processes
Material Or Material Leachate Pyrogenic Testing
Testing the device for the presence of unwanted agents (e.g.
Materials And Chemistry Evaluation
Testing devices for malfunctions that arise from problems wit
Mechanical Evaluation
Testing the device for problems that result from external force
Microbial Contamination Testing
Testing the device for the presence of microorganisms such as
Microscopic Inspection
Inspection of objects or surfaces requiring magnification usin
Mutagenic Testing
Testing the device's ability to change genetic information (u
No Testing Methods Performed
Testing was not performed on the device.
Optical Microscopy
Inspection of objects or surfaces requiring magnification usin
Overcurrent Protection Testing
Testing the device's over-current protection circuitry for its re
Packaging Verification
Verifying that the device packaging met proper sterilization c
Pathological Examination
Examining material that may have contributed to the disease
Photographic Inspection
Physical Structure Testing
Testing the device for problems related to the incorrect or i
Platelet Activation Testing
Testing the device for characteristics that lead to the activa
Power Frequency Magnetic Field Testing
Tests performed to verify a device's level of protection (immu
Power Source Testing
Testing the power sources in a device e.g., battery, internal
Pressure Testing
Testing the device's characteristics when subjected to high or
Process Evaluation
Performing a review of the manufacturing and production proce
Quality Control Review
Performing a review of the processes used in developing sys
Radiated Emissions Testing
Testing the ability of a device's radiated emissions to cause
Radiofrequency Induced Heat Testing
Testing the static magnetic field gradients on medical imaging d
Radiofrequency Interference Testing
Testing the device to detect device malfunctions caused by a di
Radiographic Inspection
Radiologic Evaluation
Evaluating the safety provisions in a device used for medical i
Reactivity Testing
Testing the device for problems related to how the materials re
Reproductive Toxicity Evaluation
Evaluating a device for chemicals or other agents that may h
Reserve Sample From Different Lot Tested, No Failure Detected
Reserve Sample Tested From Same Lot, No Failure Detected
Scaffold Evaluation
Evaluating a device's characteristics for its affects on the rep
Scanning Probe Microscopy
Inspection of objects or surfaces requiring magnification us
Shock Testing
Examining a device for problems resulting from transient phys
Simulated Use Testing
Testing the devices in situations that mimic real life settings b
Software Evaluation
Software Stress Testing
Tests conducted to evaluate a software application at or beyon
Software Validation
Validating that a system or component during or at the end o
Software Verification
A process used to verify that a system or component performs
Spectroscopy
Testing the device using a spectrometer or spectrograph for th
Static Analysis
The process of analyzing the software code without running it
Sterility Method Verification
Verifying that the methods used to free a medical device from
Sterilization Process Review
Performing a review of the records and processes used to re
Storage And Shipment Review
Performing a review of the storage and shipping processes a
Strength Testing
Testing the device's ability to resist forces that attempt to br
Stress Testing
Testing the device for failures caused by applying force per uni
Surge Protection Testing
Testing the device's ability to protect itself of other devices
Surge Response Testing
Testing for a response to a transient electrical current or volt
System Testing
Tests conducted on a complete, integrated system to evaluate
Temperature Testing
Testing the device's characteristics when subjected to temper
Test For High Temperature Conditions
Test For Low Temperature Conditions
Thermal Energy Evaluation
Testing the device for conditions related to extremes of tempe
Thrombotic Testing
Testing the device for characteristics related to forming bloo
Tissue Engineering Evaluation
Evaluating a device's characteristics that may affect tissues (
Ultrasonic Sound Testing
Testing the devices response to variations in air pressure fo
Unit Testing
Testing of individual hardware or software components or grou
Use Testing
Any testing performed that simulates real use situations expe
User Survey
Questioning a pre-defined group of users about their practice
Vibration Testing
Evaluating a device for problems resulting from periodic or
Visual Inspection
Voltage Fluctuation Testing
Wear Testing
Agglutination
Arithmetic Error
Assembly Problem
Biocompatibility Problem
Biological Problem
Carcinogenic Problem
Cleaning, Disinfecting And Sterilization Problem
Communications Problem
Complement Activation
Component Migration
Conducted Interference
Configuration Issue
Contamination By Foreign Material
Current Leakage Problem
Damage Due To Chemical Agent
Data Compression Error
Deadlock
Deformation Problem
Degradation Problem
Design Error
Dust Or Dirt Problem
Electrical Problem
Electromagnetic Compatibility Problem
Electrostatic Discharge
End Of Life Problem
Endotoxin Contamination
Energy Storage System Problem
Environment Problem
Evaluation Result
Failure To Calibrate
Fatigue Problem
Fracture Problem
Friction Problem
Genotoxic Problem
Gradient Induced Field Problem
Hardware Timing Problem
Hematologic Problem
Image Artifact
Impedance Problem
Improper Composition/Concentration
Improper Humidity
Improper Material
Improper Physical Structure
Improper Temperature
Inadequate Immunity
Inadequate Instructions For Use
Inadequate Labeling Content
Inappropriate Or Insufficient Sterilization
Incompatible Component
Incompatible Material
The device that was returned was not complete and/or is mis
The device software was found to implement an incorrect sequ
The device software was found to contain errors in specifying
A device that malfunctions because it was incorrectly installed
A device that has inadequate or incorrect insulation material.
The device software was found to contain errors in the user in
A problem with the mechanical, electrical, or communication
Insufficient, inadequate, or incorrect information provided on
The device software failed because two or more processes c
A device that experienced problems due to a loss in the powe
A device problem that occurred because of the presence of eit
Problems due to excessive torque created by the application o
A device malfunction or problem that occurs because the devic
Problems with a device that can be traced back to a problem
The undesirable presence of pyrogens or fever-producing org
Device malfunctions that arise from problems with its compone
Device problems that result from internal or external forces in
Device problems caused by the sudden violent blow or collisio
The undesirable presence of microorganisms or microbes such
Device problems related to the presence of an inappropriate
The device's ability to change genetic information (usually D
The device either functioned as designed or a failure was not
For use when no methods were performed and therefore no res
The device software contained software errors that did not imp
The device software failed to provide a safe exit from a repe
A device with an electrical circuit that does not conduct curre
Device problems that occur during the performance, use, or fu
A problem with the device's ability to pass light energy.
The device software attempted to write data outside the allo
Device packaging that is missing the insert or that contains an
Device packaging that has been opened purposefully or inadver
Reports related to the outer, protective wrapping of a device
A device that affects the body's ability to activate platelets
The device or component failed due to fluctuations within the
Problems that are related to the device that provides power.
A device that fails when the system designed to ensure its saf
Device problems that result from the failure to maintain or est
An unacceptable or unexpected RF-induced temperature rise in
A device that experienced problems due to radiofrequency inter
Problems that occur with devices used for radiographic or i
A device problem related to how the materials react inappropri
The device or component affects reproductive function, embry
For use when the evaluation is still in progress.
A device that has been used more than once without being cle
The device software attempted to access an illegal or corrup
A device that has exceeded the period of time recommended by
Device problems traced back to how the device was shipped
A device experiencing problems due to an unintentionally lowProblems with a device due the loss or weakening of a signal
The device software was not installed as per the specifications
The software requirements for the device are either incomplete
Charging Issue
Issue associated with the inability of device and/or device c
Charred
Chemical Issue
Issue associated with any deviations from device documented
Chemical Spillage
Issue associated with unintentional pouring out or releasing
Circuit Failure
Issue associated with a failure of the internal network paths or
Clumping In Device Or Device Clumping
Issue associated with the aggregation of particles into irregu
Coagulation In Device Or Devi Coagulation
Issue associated with the undesired characterization of congeal
Coiled
Collapse
Issue associated with the buckling or crushing of material fro
Communication Or Transmission Issue
Issue associated with the device sending or receiving signal
Component Falling
Component(s) Falling
Issue associated with an undesirable descent of a device compo
Component Incompatible
Component(s), Incompatible
Component Missing
Components, Missing
Issue associated with the absence of any part, substance, soft
Component Or Accessory Incompatibility
Issue associated with the incompatibility of any device and
Computer Operating System Issue
Issue associated with the machinery operating system, a coll
Computer Software Issue
Computer Software Error
Issue associated with written
Computer System Security Issue
Connection Issue
Issue associated with linking of device and/or device component
Contamination During Use
Contamination
Issue associated with the undesired introduction of impurities e
Contamination Of Device Ingredient Or Reagent
Continuous Firing
Issue associated with the excessive production of electrical i
Corrosion
Corrode|Corroded
Issue associated with the chemical or electrochemical reactio
Crack
Crack(s)|Material Crack
Issue associated with an undesired separation and/or a visible
Cross Reactivity
Issue associated with the degree to which an antibody or antig
Cut In Material
Cut(s)|Cut
Data Back-Up Problem
Issue associated with problems relating to a system, component
Data Issue
Event in which data (charting, o
Date-Related Software Issue
Issue associated with programming of calendar dates and/or ti
Decoupling
Issue associated with the device and/or device components be
Decrease In Pressure
Pressure, Decrease In
Decrease In Suction
Aspiration, Incomplete|IncomplIssue associated with the removal by suction of excess fluid o
Decreased Pump Speed
Pump Speed, Decreased
Decreased Sensitivity
Sensitivity, Decreased|Unders Issue with the device being less sensitive to an input than in
Defective Alarm
Alarm, Defective
Defective Component
Components, Defective
Issue associated with a device component having flaws of dim
Defective Item
Device, Defective
Issue associated with having flaws or dimensional deviations
Deflation Issue
Deflation Difficulties
Issue associated with the inability of device and/or device co
Degraded
Material Degradation
Issue associated with a deleterious change in the chemical str
Delamination
Issue associated with peeling of composite materials. Occurs
Delayed Alarm
Alarm, Delayed
Delayed Charge Time
Charge Times, Delayed
Issue associated with an unexpected amount of time required t
Delivered As Unsterile ProductNonsterility
Issue associated with the device being received in such a man
Delivery System Failure
Dent In Material
Dent
Deployment Issue
Issue associated with any deviations from device documented p
Detachment Of Device CompoComponent(s), Detachment O Issue associated with the unintentional separation of the dev
Detachment Of Device Or DevDevice Or Device Component ISSUE ASSOCIATED WITH THE SEPARATION OF THE DE
Device Abrasion From Instrum Abrasion From Instrument/Object
Device Alarm System Issue Alarm Failure|Alarm, Failure T Issue associated with electrical equipment or a system that d
Device Cleaning Issue
Clean, Failure To|Cleaning, I Issue associated with the insufficient removal of unwanted vis
Device Clogged
Clogged
Device Contamination With Biological Material
Device Contamination With Bl Blood Contaminated Device
Device Damaged Prior To Use Damage, Internal/External|Damaged Item|Item Damaged Prior To Use
Device Difficult To Maintain
Device Difficult To Setup Or P Prep, Difficult To
Issue associated with the use of the device in terms of user ex
Device Disinfection Or Sterilization Issue
Device Displays Error Message
Issue associated with a device prompting user with an error
Device Emits Odor
Device Expiration Issue
Expiration Date Exceeded
Issue associated with the expiration date or shelf life of a pro
Device Handling Issue
User handling not in accordance with specification.
Device Ingredient Or Reagent Issue
Device Inoperable
Device, Inoperable
Issue associated with the device being in a nonfunctional or
Device Issue
Device Failure|Malfunction
Device Maintenance Issue
Maintain, Failure To
Issue associated with the servicing of a device.
Device Markings Issue
Issue associated with the written, printed or graphic material
Device Misassembled During Manufacturing Or Shipping
Device Operates Differently Than Expected
Issue associated with any deviations from expected performa
Device Operational Issue
Issue associated with any deviations from specifications relat
Device Or Device Component Damaged By Another Device Issue associated with one device and/or device component c
Device Or Device Fragments Device/Device Fragments, Unknown Location Of
Device Packaging Compromised
Issue associated with the non-conformance to device specifi
Device Remains Activated
Issue associated with the device continuing to be in an active
Device Rinsing Issue
Rinsing, Improper
Device Sensing Issue
Issue associated with device features that are designed to res
Device Stops Intermittently
Issue associated with any deviation from device document speci
Device Unsafe To Use In Environment
Device-Device Incompatibility
Issue associated with the incompatibility of two or more dev
Difficult Or Delayed Activation Activation, Difficult /Delayed|Activation, Difficult Or Delayed
Difficult To Advance
Issue associated with difficulty moving the device or its compo
Difficult To Deploy
Deploy, Difficult To
Issue associated with users experiencing difficulty or uneasi
Difficult To Flush
Flush, Difficult To
Difficult To Fold Or Unfold
Fold, Difficult To
Issue associated with the use of the device in terms of user ex
Difficult To Insert
Insertion Difficulties
Issue associated with problems introducing or inserting the dev
Difficult To Interrogate
Interrogate, Difficult To
Issue associated with difficulty of a transponder system to tr
Difficult To Open Or Close
Issue associated with the use of the device in terms of user e
Difficult To Open Or Remove Packaging Material
Issue associated with difficulty for end-users to operate devic
Difficult To Position
Positioning Difficulties
Issue associated with the use of the device in terms of user e
Difficult To Program Or CalibraProgram, Difficult To
Issue associated with the user's ability to cause device settin
Difficult To Remove
Removal Difficulties
Issue associated with the use of the device in terms of user e
Disassembly
Disconnection
Broken Connection|Disconnec Issue associated with the linking of device and/or device com
Disinfection Or Sterilization Issue At User Location
Issue associated with the undesired introduction of impurities
Dislodged Or Dislocated
Dislocated|Dislodged
Issue associated with mechanical force that displaces devic
Display Misread
Issue associated with not correctly reading the patient or test
Dose Calculation Error Due T Dose Calculation Error
Dull
Electrical Issue
Device Electrical Issue|ElectricIssue associated with a failure of the electrical circuitry or c
Electrical Overstress
Issue associated with an electrical activity that exceeded the sp
Electrical Power Problem
Issue associated with the quality of the facility-supplied power
Electrical Shorting
Electromagnetic Compatibility Issue
Issue associated with the ability of a system to function in it
Electro-Magnetic Interference (EMI)
Issue associated with a measure of electromagnetic radiatio
Electronic Property Issue
Issue associated with any deviations from device documented pe
Electro-Static Discharge
Issue associated with the discharge of electricity between two
Emergency Power Failure
Issue associated with the failure of the facility's emergency
Failure To Reset
Reset, Failure To
Failure To Run On AC/DC
AC/DC, Failure To Run On
Failure To Run On Portable M Portable Mode, Failure To Run On
Failure To Select Signal
Signal, Failure To Select
Failure To Sense
Sensing, None
Issue associated with the failure of a device designed to resp
Failure To Separate
Separate, Failure To
Issue associated with the device or one of its components fai
Failure To Service
Service, Failure To
Issue associated with the lack of periodic preventive maint
Failure To Shock Or Properly Shock, Failure To Deliver
Issue associated with the inability of device and/or device co
Failure To Shut Off
Issue associated with the device not powering off when a sh
Failure To Spike
Spike, Failure To
Failure of device to generate a correctly-shaped pacing outpu
Failure To Sterilize
Sterilization Failure|Sterilization, Inadequate
Failure To Transmit Record
Record, Failure To Transmit
Failure To Unfold Or Unwrap Difficult To Unfold Or Unwrap Issue associated with the comprising materials' deformation in
Failure To Unwrap
Unwrap, Failure To
Issue associated with problems removing the materials used t
Failure To Zero
Zero, Failure To
False Alarm
Alarm, False
Issue associated with device providing incorrect alarm warning
False Device Output
False Output
False Negative Result
False-Negative Test Result
Issue associated with the device incorrectly reporting that s
False Positive Result
False-Positive Test Result
Issue associated with the device incorrectly reporting that s
False Reading From Device N False Readings
Issue associated with the non-compliance of the device to mee
Filling Problem
Issue associated with the method or amount of time associated
Filtration Issue
Issue associated with the process of passing a substance thro
Fire
Issues associated with the combustion of device components, r
Fitting Problem
Fitting Problems
Issue associated with the connection of device and/or device c
Flaked
Flaked Material|Flaking
Issue associated with the detachment of small pieces of the co
Flare Or Flash
Issue associated with device-related burn with an unsteady f
Flashpoint Threshold Met
Issue associated with approaching certain temperatures at whi
Fluid Leak
Fluid Leak(s)
Fogging
Issue associated with the visibility of water vapor in the imm
Folded
Fold
Foreign Material Present In DeForeign Material
Issue associated with the presence of materials, which are n
Fracture
Fracture(s) Of Device/Material Issue associated with any structural discontinuity in the materia
Free Or Unrestricted Flow
Issue associated with uncontrolled flow of infusion of air, gas o
Fumes Or Vapors
Fumes/Vapors
Issue associated with the visibility, odor, or toxicity of an am
Fungus In Device Environmen Fungus
Issue associated with the visibility of molds, mildews, yeast
Gas Leak
Issue associated with the unintended escape of a gas from the
Gel Leak
Gel Leakage
Gradient Increase
Issue associated with the increased rate of change in temperat
Grounding Malfunction
Issue associated with the inability to connect conductors of a
High Battery Impedance
High Capture Threshold
Capture Threshold, High
Issue associated with the amount of output energy needed to
High Impedance
Impedance, High
Issue associated with higher than intended electrical imped
High pH
pH, High
High Readings
Readings, High
High Sensing Threshold
Sensing Threshold, High
Issue associated with the amount of input required by the dev
High Test Results
Test Results, High
Hole In Material
Hole(s)|Hole
Issue associated with an opening not characteristic of the nor
Hot Oil Leak
Human Factors Issue
Issue associated with the interaction and interfacing between
Human-Device Interface Issue
Image Display Error
Event in which measurement functions produce erroneous resu
Image Orientation Incorrect
Issue associated with an incorrect image orientation on the de
Image Resolution Poor
Image Reversal
Impedance Issue
Issue associated with electrical impedance levels between d
Imprecision
Improper Alarm
Improper Chemical Reaction
Issue associated with an unexpected or inappropriate chemical
Improper Device Output
Issue associated with the inaccurate outcome of a measureme
Improper Flow Or Infusion
Issue associated with the unsubstantiated regulation and delive
Improper Gas Output
Gas Output, Improper
Improper Or Incorrect Proced Improper Or Incorrect Method| Issue associated with the use of the device in terms of non-c
Inability To Autofill
Autofill, Unable To
Inability To Irrigate
Irrigate, Inability To
Inaccurate Delivery
Delivery, Inaccurate
Inaccurate Dispensing
Inaccurate Flowrate
Flowrate, Inaccurate
Inaccurate Synchronization
Synchronization, Inaccurate Issue associated with an error due to imperfect timing of two
Inadequate Filtration Process Filtration Process, Inadequate
Inadequate Instructions For HeInstructions, Incorrect
Issue associated with inaccuracies in any written, printed, or
Inadequate Instructions For Non-Healthcare Professional
Issue associated with users being unclear and not able to foll
Inadequate Lighting
Issue associated with an inappropriate level of light or illum
Inadequate Service
Service, Inadequate
Issue associated with inadequate periodic preventive maint
Inadequate Storage
Storage Inadequate|Storage, Issue associated with inadequate or inappropriate storage of
Inadequate Training
Issue associate with facility not providing satisfactory initial
Inadequate User Interface
Issue associated with the means by which the operator and t
Inappropriate Or Unexpected Reset
Issue associated with the inability to appropriately perform o
Inappropriate Prompts
Prompts, Inappropriate
Inappropriate Shock
Shock, Inappropriate
Issue associated with the inappropriate delivery of an electric
Inaudible Voice Prompts
Prompts, Inaudible Voice
Incompatibility Problem
Compatibility
Issue associated with the device not being compatible with an
Incomplete Coaptation
Issue associated with the heart valve leaflet not closing prope
Incomplete Or Missing PackagPackaging, Incomplete/Missing
Incorrect Device Or Component Shipped
Issue associated with the delivery of an inappropriate device
Incorrect Display
Display, Incorrect
Issue associated with device failure and malfunction when de
Incorrect Error Code
Incorrect Interpretation Of Rh Rhythm, Incorrect Interpretation Of
Incorrect Measurement
Measurements, Inaccurate
Incorrect Or Inadequate Resul Results Incorrect
Issue associated with a non-conforming end result, data, or te
Incorrect Or Inadequate Test RTest Results, Inaccurate
Incorrect Software ProgramminProgramming Calculations, Incorrect
Increase In Pressure
Pressure, Increase In
Increase In Suction
Aspiration, Excessive|Excessive Aspiration|Suction, Increase In
Increased Pump Speed
Pump Speed, Increased
Increased Sensitivity
Oversensing|Sensitivity, Incre Issue with the device being more sensitive to an input than i
Inflation Issue
Inflation Difficulties
Issue associated with the inability of a device and/or device c
Infusion Or Flow Issue
Issue associated with the device failing to deliver liquids or g
Installation-Related Problem Installation Error
Issue associated with unsatisfactory installation, configuratio
Instruction For Use Issue
Instructions, Inadequate
Issue associated with the accuracy and appropriateness of any
Insufficient Cooling
Cooling, Inadequate
Issue associated with device or device parts being insufficie
Insufficient Flow Or Underinfu Underdelivery|Underinfusion Issue associated with an underdose of intravenous therapy, i.
Insufficient Heating
Heating, Inadequate
Issue associated with the device or its components producing
Intermittent Capture
Capture, Intermittent
Issue associated with the ineffective and inconsistent depolari
Intermittent Continuity
Continuity, Intermittent
Intermittent Infusion
Infusion, Intermittent
Intermittent Shock
Shock, Intermittent
Issue associated with the failure to deliver shock for a limited
Invalid Sensing
Sensing, Invalid
Issue associated with the inaccuracy of a device designed to r
Issue With Displayed Error Message
Issue associated with error messages that are undecipherable
Item Contaminated During Manufacturing Or Shipping
Issue associated with the presence of any unexpected foreign
Kinked
Kink|Kinked Material
Knotted
Knot|Knotted Material
Lack Of Maintenance Documentation Or Guidelines
Issue associated with user facility not receiving adequate
Leak
Leak(s)
Issue associated with the escape of a liquid or gas from the v
Light Interference
Looping
Loose Or Intermittent Connect Connection(s), Loose
Loss Of Data
Data Corruption|Data Loss
Event in which information is unintentionally permanently or te
Loss Of Or Failure To Bond Bond, Failure To
Issue associated with lack or loss of adherence between mate
Loss Of Osseointegration
Osseointegration, Loss Of
Loss Of Power
Power, Loss Of
Issue associated with the failure of primary power supplied by t
Loss Of Threshold
Threshold, Loss Of
Issue associated with the loss of the minimum amount of energ
Low Audible Alarm
Alarm, Low Audible
Low Battery
Battery, Low
Low Battery Impedance
Low Impedance
Impedance, Low
Issue associated with lower than intended electrical impeda
Low Readings
Readings, Low
Low Sensing Threshold
Sensing Threshold, Low
Issue associated with the amount of an input required by the
Low Test Results
Test Results, Low
Maintenance Does Not Compl Maintenance Not To Manufact Issue associated with the non-compliance or non-performance to
Malposition Of Device
Malposition
Issue associated with device being positioned in a location ot
Manufacturing Or Shipping Issue Associated With Device
Issue associated with any deviations from device documented
Material Deformation
Issue associated with an undesired material change in shape
Material Discolored
Discolored
Issue associated with an undesired streak, pattern, and/or a n
Material Disintegration
Disintegrate
Issue associated with material breaking into small fragments o
Material Distortion
Issue associated with undesired physical appearance of devic
Material Erosion
Erosion
Issue associated with a progressive loss of a material from a
Material Fragmentation
Fragmentation
Issue associated with small pieces of the device breaking off
Material Frayed
Frayed
Issue associated with the comprising materials having dama
Material Integrity Issue
Issue associated with any deviations from device documented pe
Material Invagination
Invagination
Material Opacification
Opacification|Opaque
Issue associated with an undesirable opaqueness or cloudine
Material Perforation
Perforation
Issue associated with an undesired material damage characte
Material Protrusion
Issue associated with undesired physical appearance of devic
Material Puncture
Puncture
Issue associated with the comprising material(s) being penetr
Material Rigid Or Stiff
Rigid Or Stiff|Rigid
Material Rupture
Rupture
Issue associated with the bursting or tearing apart of a materi
Material Separation
Separates|Separation
Issue associated with an undesired disassociation or breaking
Material Torqued
Torqued
Issue associated with a movement of forces that produces or t
Material Twisted
Twisting
Measurement System Incompatibility
Issue associated with the incompatibility of the measuremen
Mechanical Issue
Mechanical Failure
Issues associated with any deviations from device documented
Mechanical Jam
Issue associated with a problem that prevents or restricts the
Mechanics Altered
ISSUE ASSOCIATED WITH DEVICE MECHANICAL FUNCTI
Medical Gas Supply Problem
Issue associated with the facility-supplied medical gases such
Medication Error
Event in which the device softw
Melted
Material Molten|Melts
Issue associated with a solid device or device components bei
Metal Shedding Debris
Debris, Metal Shedding
Migration Of Device Or Devic Migration
Issue associated with an undesired movement of device and/o
Misassembled
Misassembly
Issue associated with the use of the device characterized by
Misassembled By Users
Misconnection
Improper Connection
Issue associated with the connection of device and/or device
Misfire
Issue associated with failure of device to discharge its load (e.
Misfocusing
Missing Test Results
Test Results, Missing
Issue associated with the results of a test or measurement n
Missing Value Reason
Moisture Damage
Issue associated with damage inflicted upon the device or d
Moisture Or Humidity Problem
Issue associated with an unsatisfactory humidity level in the
Mushroomed
Naturally Worn
Issue associated with material damage to a surface, usually i
No Code Available
No Device Output
Output, None
Issue associated with no measurement outcome, value, or dat
No Display Or Display Failure Display, Failure To
Issue associated with the absence of visual indicator.
No Fail-Safe Mechanism
No Flow
Issue arising from the device failing to deliver the specified li
No Information
No Answer Provided
No Known Device Problem
No Pacing
Issue associated with the device ceasing to deliver paces.
No Pressure
No Voice Prompts
Prompts, No Voice
Noise, Audible
Acoustic Noise|Audible Noise| ISSUE ASSOCIATED WITH
Nonstandard Device Or Device Component
Issue associated with a material that does not meet the specif
Not Applicable
If a value for test has to be pro
Not Audible Alarm
Alarm, Not Audible
Obstruction Within Device
Obstruction
Occlusion Within Device
Occlusion|Plugged
Issue associated with an obstruction or blockage within any of
Operating System Becomes Non-Functional
Issue associated with malfunction of the computer operating
Operating System Version Or Upgrade Problem
Issue associated with replacing an older operation system to
Optical Decentration
Lens, Decentration Of
Issue associated with being off-center of optical lenses.
Optical Discoloration
Issue associated with an optical streak or other pattern on th
Optical Distortion
Issue associated with an optical defect in an image-forming
Optical Issue
Issue associated with problems transmitting visible light affect
Optical Obstruction
Issue associated with the blocking of optical devices, e.g., vi
Osseointegration Issue
Issue associated with interconnection between bone tissue a
Out-Of-Box Failure
Output Above Specifications
Output Below Specifications
Output Energy Incorrect
Output Issue
Issue associated with any deviation from device documented pe
Overcorrection
Issue associated with an adjustment that surpasses a set crit
Overfill
Overheating Of Device Or De Overheat
Issue associated with the device producing high temperatures
Oversensing
Pacer Found In Back-Up Mode
Pacing Asynchronously
Issue associated with a pacing transmission process such that
Pacing Inadequately
Pacing voltage or pulse width is less than desired.
Pacing Intermittently
Issue associated with the failure of pacing device for a limited
Packaging Issue
Issue associated with the materials used to construct the cov
Parameter Calculation Error Parameter Calculations, Incorrect
Particulates
Substances that consist of separate particles that are introd
Patient Data Issue
Event in which information is a
Patient-Device Incompatibility
Issue associated with the interaction between the patient's ph
Peeled
Peeled Device Material|Peelin Issue associated with stresses of sufficient magnitude to excee
Perivalvular Leak
Leak(s), Perivalvular|Paravalv Issue associated with the escape of blood around a heart valve,
Physical Property Issue
Device Physical Property Issu Issue associated with any deviations from specifications relat
Physical Resistance
Resistance, Physical
Pitted
Pitting
Issue associated with the corrosion of a material's surface, co
Plunge
Pocket Stimulation
Issue associated with a pocket of skin in which the pulse gen
Poor Quality Image
Monitor, Image Quality Poor Issue associated with an image or any visual representation di
Positioning Issue
Issue associated with the movement of the device and/or dev
Power Calculation Error Due Power, Miscalculation Of
Power Conditioning Issue
Issue associated with inadequate power conditioning such as t
Power Source Issue
Pre Or Post-Pumping ProblemPre/Post-Pumping Problems
Precipitate In Device Or Devic Precipitate
Issue associated with the separation of solid particles from a
Premature Deployment
Premature System Activation Issue associated with an early and unexpected deployment o
Premature Discharge Of Batte Battery, Premature Discharge Of
Premature Elective Replacemen
Premature ERI
Premature End-Of-Life Indicat Premature EOL
Premature Indicator Activation
Pressure Issue
Issue associated with the application of a force either interna
Problem With Software Installation
Issue associated with installing the device software in a manne
Product Quality Issue
Device Or Device Component Qu
Issue associated with an inherent device and/or device compone
Programming Issue
Issue associated with the written program code or application
Prompts Will Not Clear
Protective Measure Issue
Issue associated with any deviations from device documented pe
Pumping Issue
Issue associated with pump performance deviating from specif
Pumping Stopped
Pumping, Stopped
Radiation Leak
Leak, Radiation
Radiation Overexposure
Issue associated with excessive radiation emitted from radiolo
Radiation Underexposure
Issue associated with too little radiation emitted from radiolo
Radio Signal Problem
Radio Signal Problems
Issue associated with the wireless transmission signal in the
Radiofrequency Interference (RFI)
Issue associated with the degradation of the reception of a
Reflux Within Device
Reflux
Issue associated with a backward or return flow.
Rejection
Reset Issue
Issue associated with setting a variable, register, or other sto
Residue After Decontaminatio Residue
Issue associated with the decontamination process not adequa
Restricted Flowrate
Flowrate, Restricted
Retraction Problem
Retract, Failure To
Issue associated with drawing back the device and/or device
Scratched Material
Scratched
Issue associated with an undesirable shallow cut or narrow gr
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
Self-Activation Or Keying
Self-Activation/Keying
Issue associated with the unintended activation of device, o
Sensing Intermittently
Shelf Life Exceeded
Issue associated with the using a device after the marked or k
Shielding Failure
Issue associated with device inability to act as a barrier for
Shipping Damage Or Problem
Short Fill
Size Incorrect For Patient
Size, Incorrect
Slippage Of Device Or Devic Slippage
Smoking
Smoke
Issue associated with a cloud of vapor or gas generated from t
Solder Joint Failure
Spark
Issue associated with a flash of light related to an electrical
Split
Material Split|Splitting
Issue associated with a partial or full-thickness crack in the d
Sticking
Stretched
Material Stretched
Issue associated with an increase or elongation in a material
Strikethrough
Structural Problem
Structural Failure
Issue associated with the basic physical construction or phys
Suction Issue
Suction Failure
Issue associated with suction equipment, which may be a manu
Tear, Rip Or Hole In Device P Packaging, Tears, Rips, Holes In
Telemetry Discrepancy
Issue associated with variability of the transmission of sign
Temperature Issue
Issue associated with the device producing unintended tempe
Therapeutic Or Diagnostic Output Failure
Issue associated with the failure of the device to deliver any e
Therapy Delivered To Incorrect Body Area
Issue associated with the device causing unintended therapeut
Tidal Volume Fluctuations
Issue associated with the amount of gas that is inspired and e
Tipover
Device Tipover
Torn Material
Issue associated with comprising material(s) being pulled apar
Ultrafiltration
Issue associated with the transfer of fluid between the bloo
Unable To Obtain Readings Readings, Unable To Obtain
Unauthorized Access To Computer System
Issue associated with an access that was not permitted to the
Uncoiled
Undersensing
Unexpected Therapeutic ResulTherapeutic Results, Unexpec Issue associated with the use of a medical device for therape
Unintended Arm Motion
Arm Motion, Unintended
Unintended Collision
Collision, Unintended
Issue associated with device or device components impacting
Unintended Ejection
Film Cartridge Ejection, Unint Issue associated with unexpected discharge of device from expe
Unintended Energization
Device Energization, Unintended|Unintended Device Energization
Unintended Head Motion
Head Motion, Unintended
Unintended Magnet Quench Magnet Quench, Unintended
Unintended Movement
Issue associated with an unde
Unintended System Motion
System Motion, Unintended Issue associated with any motion of the system or components
Unraveled Material
Unsealed Device Packaging Packaging, Unsealed
Unstable
Issue associated with the connection of device and/or device
Unstable Capture Threshold Capture Threshold, Unstable Issue with the amount of output energy needed to cause cardi
Use Of Device Issue
Device, Incorrect Care/Use Of Issue associated with user's failure to process, service, or
Use Of Incorrect Control Setti Control Settings Incorrect
Issue associated with the use of the device in terms of inappr
User Used Incorrect Product FProduct, Incorrect
Ventilation Issue In Device Environment
Vibration
Issue associated with an oscillation wherein the quantity is
Volume Accuracy Issue
Volume Accuracy
Wireless Communication Issue
Issue related to the transmissi
Wrinkled
Wrinkled Material|Wrinkling
Abdominal Cramps
Cramps, Abdominal
Abortion
Abortion, Complete
All products of conception are
Abortion, Incomplete
The uterus is not entirely empti
Abortion, Induced
Abortion, Artificial|Artificial A Abortion brought on intentional
Abortion, Missed
Retention in uterus of an abor
Abrasion
Abraded wound; excoriation or
Abscess
Achalasia
Failure of the smooth muscle fib
Acoustic Trauma
Adhesion(s)
Adult Respiratory Distress Sy Adult Respiratory Distress Syndrome, ARDS
AIDS, Acquired Immunodefici Acquired Immunodeficiency Syndrome, AIDS
Air Embolism
The presence of bubbles of gas
Airway Obstruction
Alteration In Body Temperature
Ambulation Difficulties
Difficulties, Ambulation
Amnionitis
Inflammation of the amnion.
Anaphylactoid
Anaplastic Large Cell Lymph ALCL
Anastomose, Failure To
Anemia
Anesthesia, Insufficient, Light Insufficient, Light Or Patchy Anesthesia|Light, Patchy Or Insufficient Anesthesia|Patchy, Ligh
Aneurysm
Angina
Anoxia
Antibiotics, Reaction To
Anxiety
Aortic Dissection
Dissection, Aortic
Aortic Insufficiency
Aortic Regurgitation
The backward flow of blood from
Aortic Stenosis
Narrowing of the orifice of the
Apgar Score, Decreased Or L Decreased Or Low Apgar Score|Low Or Decreased Apgar Score|Score, Decreased Or Low
Apheresis
Apicectomy
Apnea
Arrest, Respiratory|RespiratoryCessation of breathing.
Arachnoiditis, Spinal
A chronic adhesive arachnoidit
Arrhythmia
Arteriosclerosis
Arthralgia
Joint Pain|Pain, Joint
Pain in a joint.
Arthritis
Arthritis, Rheumatoid
Rheumatoid Arthritis
Ascites
Asphyxia
A condition due to lack of oxyge
Aspiration
Asthma
Atherosclerosis
Atrial Fibrillation
An arrhythmia in which minute a
Atrial Flutter
Atrial Perforation
Atrial Tachycardia
Autoimmune Disease
Disease, Autoimmune
Autoimmune Reaction
Reaction, Autoimmune
Biliary Cirrhosis
Cirrhosis, Biliary
Blinking, Excessive
Excessive Blinking
Blood Gas Measurements, Ab Abnormal Blood Gas Measurements|Measurements, Abnormal Blood Gas
Blood Loss
Loss Of Blood
Blurred Vision
Blurring|Vision, Blurring Of
Bowel Perforation
Bradycardia
Decreased Heart Rate|Heart Rate, Decreased
Brain Injury
Brain Damage|Injury, Brain
Breast Lumps
Lumps, Breast
Breast Neoplasm
Neoplasm, Breast
Bronchitis
Bronchopneumonia
Bronchospasm
Bruise
Burn(s)
Injury to tissues caused by con
Burn, Bowel
Bowel Burn
Burn, Corneal
Corneal Burn
Burn, Thermal
Burns, Thermal|Thermal Burn
Burning Sensation
Sensation, Burning
Calcification
Calcium Deposit(s)|Deposit(s), Calcium
Cancer
Malignant Neoplasm
Cancer, Breast
Breast Cancer
Capsular Bag Tear, Posterior
Capsular Contracture
The tightening of scar tissue t
Cardiac Arrest
Arrest, Cardiac|Asystole
Sudden cessation of the pumping
Cardiac Perforation
Cardiac Tamponade
Acute compression of the heart
Cardiomyopathy
Cardiopulmonary Arrest
Arrest, Cardiopulmonary
Cessation of breathing and/or
Cataract
Cataract, Induced
Induced Cataract
A cataract that has been produce
Caustic/Chemical Burns
Burn, Caustic/Chemical|Chemical/Caustic Burn
Cellulitis
Cephalohematoma
A subperiosteal hemorrhage lim
Cerebral Ventriculomeglia
Ventriculomeglia
Cerebrospinal Fluid Leakage Fluid, Leakage Of Cerebrospinal|Leakage Of Cerebrospinal F
Cerebrovascular Accident
CVA, Cerebrovascular Accident|Cerebrovascular Accident, (
Cervical Changes
Cervical Change|Changes, CerChanges such as abnormal, pathological, benign, malignant,
Chemical Exposure
Exposure, Chemical
Chemosis
Excessive edema of the ocular
Chest Pain
Pain In Chest
Chest Tightness/Pressure
Pressure/Tightness In Chest|Tightness/Pressure In Chest
Chills
Choking
Chorioamnionitis
Chronic Obstructive Pulmonar COPD, Chronic Obstructive Pulmonary Disease|Disease (COP
Claudication
Limping or lameness.
Closed Capsulotomy
Clouding, Central Corneal
Central Corneal Clouding|CornDiffuse edema of the central region of the cornea, usually as
Coagulopathy
Cognitive Changes
Changes, Cognitive
Pertaining to or characterized by cognition. That operation o
Collapse
Coma
Comatose
Complaint, Ill-Defined
Ill-Defined Complaint
Complete Heart Block
Concussion
A violent jar or shock, or the c
Confusion/Disorientation
Disorientation/Confusion
Congenital Defect/Deformity Defect/Deformity, Congenital|Deformity/Defect, Congenital
Congestive Heart Failure
Failure, Congestive Heart|Heart Failure, Congestive
Conjunctivitis
Connective Tissue Disease
Disease, Connective Tissue|Tissue Disease, Connective
Constipation
Contusion
A bruise; an injury of a part wi
Convulsion, Clonic
Clonic Convulsion
A convulsion marked by alterna
Convulsion, Tonic
Tonic Convulsion
Prolonged contraction of the mu
Cornea, Perforation Of
Perforation Of Cornea
Corneal Abrasion
Corneal Decompensation
Decompensation, Corneal
Inability to maintain corneal i
Corneal Edema
Edema, Corneal
Hazy, swollen cornea.
Corneal Haze
Corneal Infiltrates
Infiltrates, Corneal
Discrete, small lesions presen
Corneal Scar
Scar, Corneal
Corneal Touch
Touch, Corneal
Complications of intraocular le
Corneal Ulcer
Ulcer, Corneal
Area of epithelial tissue loss
Cramp(s)
Cross-Patient Exposure To BodBlood/Fluids, Contamination The patient becomes contamina
Crushing Injury
Injury, Crushing
Cusp Tear
Cyanosis
Cyclitis
Inflammation of the ciliary bod
Cyst(s), Formation Of
Formation Of Cyst(s)
Cytomegaloviral Retinitis
Retinitis, Cytomegaloviral
Cytomegalovirus (CMV)
CMV, Cytomegalovirus
Deafness
Death
Expired/Death
Death, Intrauterine Fetal
Fetal Death, Intrauterine|Intra Death in utero; failure of the
Debris, Bone Shedding
Bone Shedding Debris|Sheddi Shedding of accumulated bone
Decreased Apgar
Decreased Sensitivity
Dehiscence Of Organ
Dehydrated
Dementia
Dementia, Dialysis
Dialysis Dementia
A severe, often fatal encephal
Deposits
Depression
Dermatomyositis
Detached Retina
Retina, Detached
Device Fragments In Patient
Issue associated with the inability to retrieve device and/or
Diabetic Ketoacidosis
Ketoacidosis, Diabetic
A type of metabolic acidosis p
Diaphoretic
Pertaining to or characterized
Diarrhea
Difficulty Chewing
Disability
Disc Impingement
Discharge
Discomfort
Disfigurement
Dissection
Disseminated Intravascular CoCoagulation (DIC), DisseminatA disorder characterized by red
Distention
Distress
Dizziness
Dry Eye(s)
Eye(s), Dry
Dyskinesia
Difficulty moving; distortion o
Dysphagia
Dysphasia
Dyspnea
Breathing Difficulties|Difficulty Breathing
Dysuria
Difficulty or pain in urination.
Ecchymosis
Edema
Edema, Macular
Macular Edema
Edema, Microcystic
Microcytic Edema
Edema, Stromal
Stromal Edema
Fluid from the aqueous humor
EKG/ECG Changes
Changes In EKG/ECG|ECG/E Changes in cardiac electrical ac
Electric Shock
Electrical Shock|Shock, Electric|Shock, Electrical
Electrocution
The passage of electrical curr
Electrolyte Imbalance
Imbalance, Electrolyte
Higher or lower than normal va
Electro-Mechanical Dissociati Dissociation, Electro-MechanicContinued electrical rhythmicit
Embolism
Embolus
A mass of clotted blood or othe
Emotional Changes
Changes, Emotional
Emphysema, Pulmonary
Pulmonary Emphysema
A condition of the lung characte
Encephalitis
Encephalopathy
Endocarditis
Endophthalmitis
Enzyme Elevation, Cardiac
Cardiac Enzyme Elevation|Elevation Of Cardiac Enzymes
Erosion
An eating away or breakdown of
Eructate
To belch, the casting of upwin
Erythema
Esophagus, Laceration(s) Of Laceration(s) Of Esophagus
Esophagus, Perforation Of
Perforation Of Esophagus
Exit Block
Exsanguination
Extensive loss of blood due to
Extravasation
A discharge or escape, as of bl
Extreme Exhaustion
Exhaustion, Extreme
Extreme fatigue; inability to re
Extubate
Eye Injury
Injury, Eye
Facial Nerve Paralysis
Nerve Paralysis, Facial|Paralysis Of Facial Nerve
Fainting
Extremely weak; threatened wi
Fall
Fasciitis
Inflammation of fascia.
Fatigue
Feeding Problems
Problems, Feeding
Fetal Distress
Distress, Fetal
Fever
Fibromyositis
Inflammation and fibrous dege
Fibrosis
The formation of fibrous tissue
First Use Syndrome
Syndrome, First Use
A symptom complex characterize
First-Degree Burn
A burn that only affects the ou
Fistula
Flashers
A sudden or brief burst of light
Flatus
Gas or air in the gastrointestina
Fluid Discharge
Forced Expiratory Volume, De Decreased Forced Expiratory A decrease in the fraction of t
Forced Expiratory Volume, Inc FEV Increased|FEV, (Forced Ex
An increase in the fraction of
Foreign Body In Patient
An occurrence where any object originating inside or outside
Foreign Body Reaction
Reaction, Foreign Body
A granulomatous inflammatory r
Foreign Body Sensation
Sensation, Foreign Body
Feeling of grittiness or having
Fracture(s)
Fracture, Arm
Fracture, Delayed Union
Delayed Union Fracture|Union Fracture, Delayed
Fracture, Hip
Hip Fracture
Fracture, Skull
Skull Fracture
Fracture, Tooth
Tooth Fracture
Fungus
Gangrene
Death of tissue, usually in con
Gastritis
Glaucoma
Granuloma
Great Vessel Perforation
Perforation, Great Vessel
Hair Loss
Loss Of Hair
Halo
Hazy ring around bright lights s
Head Injury
Injury, Head
Headache
Headache, Lumbar Puncture Headache, Post Spinal|LumbaHeadache in erect position, aft
Healing, Impaired
Impaired Healing
Hearing Impairment
Impairment, Hearing
Hearing Loss
Loss Of Hearing
Heart Failure
Cardiac Insufficiency|Failure, Inability of the heart to pump b
Heartburn
Heavier Menses
Hematoma
A localized collection of blood,
Hematuria
Hemoconcentration
An increase in the concentratio
Hemolysis
Hemolytic Anemia
Anemia, Hemolytic
Hemoptysis
Hemorrhage
Bleeding
Hemorrhage, Cerebral
Bleeding, Cerebral|Cerebral Hemorrhage into the cerebrum
Hemorrhage, Extradural
Extradural Hemorrhage
Intracranial hemorrhage into t
Hemorrhage, Intraventricular Intraventricular Hemorrhage
Hemorrhage, Subarachnoid Subarachnoid Hemorrhage
Intracranial hemorrhage into
Hemorrhage, Subdural
Subdural Hemorrhage
Cerebral hemorrhage into the
Hemorrhage, Subgaleal
Hemorrhage, Subgaleal
Hemostasis
The arrest of bleeding, either
Hemothorax
A collection of blood in the pleu
Hepatitis
Hernia
Herpes
Any inflammatory skin disease
Hiccups
HIV, Human ImmunodeficiencyHuman Immunodeficiency Virus
A cytopathic retrovirus. It is th
Host-Tissue Reaction
Reaction Of Host-Tissue|TissuGrowth of tissue in or around
Hot Flashes
Flashes, Hot
Hydrocephalus
Hyperbilirubinemia
Excessive concentrations of bil
Hyperemia
The presence of an increased
Hyperglycemia
Blood Glucose, High|Glucose, High Blood|High Blood Glucos
Hypernatremia
Hyperplasia
Hypersensitivity
Allergic Reaction
Hypersensitivity; a local or ge
Hypertension
Blood Pressure, High|Blood Pressure, Increased|High Blood
Hyperthermia
Hyperventilation
Abnormally prolonged, rapid,
Hypervolemia
Hyphema
Hemorrhage within the anterio
Hypoesthesia
Consisting of abnormally decrea
Hypoesthesia, Arm/Hand
Consisting of abnormally decreased sensitivity, particularly to
Hypoesthesia, Foot/Leg
Foot/Leg Hypoesthesia|Leg/FoConsisting of abnormally decreased sensitivity, particularly to
Hypoglycemia
Blood Glucose, Low|Glucose, Low Blood|Low Blood Glucose
Hypopyon
An accumulation of pus in the
Hypotension
Blood Pressure, Decreased|Blood Pressure, Low|Decreased
Hypothermia
Body Temperature, DecreasedAbnormally low body temperat
Hypoventilation
A state in which there is a red
Hypovolemia
Abnormally decreased volume of
Hypoxia
Hypoxia In Utero
Caused by conditions such as in
Iatrogenic Source
Source, Iatrogenic
Idioventricular Rhythm
Rhythm, Idioventricular
Relating to or affecting the car
Immuno-Deficiency
A deficiency of immune respon
Implant, Failure Of
Failure Of Implant
An object or material, such as an alloplastic or radioactive mat
Impotence
Inadequate Osteointegration
Incompetent Cervix
Cervix, Incompetent
One that is abnormally prone to
Incontinence
Increased Sensitivity
Sensitivity
Infarction, Cerebral
Cerebral, Infarction
An ischemic condition of the bra
Infection
Infection, Bacterial
Bacterial Infection
Infection, Direct
Direct Infection
Infection produced by direct c
Infection, Fungal
Fungal Infection
Infection, Indirect
Indirect Infection
Infection transmitted by water, food or other means of conve
Infection, Intraocular
Intraocular Infection
Infection within the eye.
Infection, Pyrogenic
Pyrogenic Infection
An infection caused by pus-pr
Infection, Subclinical
Subclinical Infection
Infection associated with no
Infection, Upper Respiratory Tract
Infection, Urinary Tract
Tract, Infection Of Urinary|Urinary Tract Infection
Infection, Viral
Viral Infection
Infiltration Of Tissue
Infiltrates
To penetrate a tissue or subst
Inflammation
Injury
Insufficiency, Valvular
Valvular Insufficiency
Dysfunction of one of the cardi
Intermenstrual Bleeding
Intimal Dissection
Dissection, Intimal
Pertaining to the inner layer of the blood vessels.
Intracranial Hemorrhage
Bleeding, Intracranial|Hemorrha
Bleeding within the cranium.
Intraocular Pressure Rise
IOPR, Intraocular Pressure RisIncrease of pressure of the intr
Intraocular Pressure, Delayed,Delayed, Uncontrolled IntraocuChanges in the fluid pressure inside the eye.
Intraoperative Pain
Iritis
Inflammation of the iris.
Irritability
Irritation
Ischemia
Ischemic Heart Disease
Disease, Ischemic Heart|Heart Disease, Ischemic
Itching
Jaundice
Joint Dislocation
Dislocated Joint
Joint Disorder
Disorder, Joint
Joint Swelling
Swelling, Joint
Keratitis
Keratitis, Acanthamoeba
Acanthamoeba Keratitis
Keratitis due to infection by a
Labor, Premature
Premature Labor
Laceration(s)
Lead(s), Burn(s) From
Lead(s), Shock From
Left Ventricular Dysfunction Dysfunction, Left Ventricular|Ventricular Dysfunction, Left
Left Ventricular Failure
Failure, Left Ventricular|VentricFailure of adequate output by
Left Ventricular Hypertrophy Ventricular Hypertrophy, Left Enlargement or overgrowth of t
Lethargic
Ligament(s), Damage To
Damage To Ligament(s)
Limited Mobility Of The Implanted Joint
Liver Contusion
Contusion, Liver
Bruising of the liver.
Liver Dysfunction
Dysfunction, Liver
Liver Laceration(s)
Laceration(s), Liver
Loss Of Consciousness
Loss Of Pulse
Pulse, Loss Of
Low Cardiac Output
Cardiac Output, Low|Output, Low Cardiac
Lung, Overinflation Of
Overinflation Of Lung
Lupus
Lymphoma
Malaise
Mammogram, Abnormal
Abnormal Mammogram
Mediastinal Shift
Shift, Mediastinal
Normal location of the mediastinum changes to the right or l
Memory Loss
Loss Of Memory
Meningitis
Menstrual Irregularities
Irregularities, Menstrual
Deviations from the normal proc
Microcysts, Epithelial
Epithelial Microcysts
Very small, round vesicles con
Micturation Urgency
A sudden compelling urge to ur
Miscarriage
Loss of the products of concep
Misdiagnosis
Missed Dose
Dose, Missed
Missing Value Reason
Mitral Insufficiency
Insufficiency, Mitral
Mitral Perforation
Perforation, Mitral
Mitral Regurgitation
Regurgitation, Mitral
The backward flow of blood from
Mitral Stenosis
Stenosis, Mitral
Narrowing of the left atrioventri
Mitral Valve Prolapse
Prolapse, Mitral Valve|Valve, PProlapse of the mitral valve, of
Multiple Organ Failure
A progressive condition usually
Muscle Spasm(s)
Spasm(s), Muscle
A sudden, violent, involuntary
Muscle Stimulation
Stimulation Of Muscle
Muscle Weakness
Weakness, Muscular
Muscular Rigidity
Rigidity, Muscular
Stiffness or inflexibility.
Muscular Tics
An involuntary, compulsive, re
Myalgia
Myocardial Contusion
Cardiac Contusion|Contusion, A bruise to the heart.
Myocardial Infarction
Infarction (MI), Myocardial|MI, Gross necrosis of the myocardiu
Myocarditis
Nasal Obstruction
Obstruction, Nasal
Nausea
Necrosis
Necrosis Of Flap Tissue
Flap Tissue, Necrosis Of|Tissue, Necrosis Of Flap
Needle Stick/Puncture
Puncture/Stick From Needle|Stick/Puncture From Needle
Neonatal Deformities
Deformities, Neonatal
Neonatal Hearing Impairment Hearing Impairment, Neonatal|Impairment To Hearing, Neona
Neonatal Hearing Loss
Hearing Loss, Neonatal|Loss Of Hearing, Neonatal
Neovascularization
Nerve Damage
Damage To Nerve(s)
Nerve Proximity Nos (Not Otherwise Specified)
Nerve Stimulation, Undesired Stimulation Of Nerve, Undesired|Undesired Nerve Stimulation
Nervous System Injury
Neurological Deficit/Dysfuncti Deficit/Dysfunction, Neurological|Dysfunction/Deficit, Neurolo
Neuropathy
Nipple Sensation, Changes In Changes In/Loss Of Nipple Sensation|Loss Of/Changes In Nipple Sensation|Sensation, Cha
Nipple Ulceration
Ulceration, Nipple
No Code Available
No Consequences Or Impact TConsequences Or Impact To Patient, None|Impact Or Consequences To Patient, None|Pati
No Information
No Answer Provided
No Known Impact Or Consequence To Patient
No Patient Involvement
Nonpyrogenic
Not Applicable
If a value for test has to be pro
Numbness
Obstruction
Occlusion
The act of closure or the stat
Optical Nerve Damage
Damage To Optical Nerve(s)|Nerve Damage, Optical
Optical Tissue, Breakdown Of Tissue, Breakdown Of Optical
Organ(s), Perforation Of
Perforation Of Organ(s)
Ossification
The formation of bone or of a
Osteolysis
Dissolution of bone; applied es
Osteopenia
Bone Loss
Overdose
Oversedated
Overstimulation
Overwear Syndrome
Syndrome, Overwear
Ocular pain which may be very
Oxygen Saturation, High
High Oxygen Saturation|Satur The calculated measurements i
Oxygen Saturation, Low
Low Oxygen Saturation|SaturaThe calculated measurements i
Pain
Pain Relief, Inadequate
Inadequate Pain Relief
Pain, Abdominal
Abdominal Pain
Pain, Neck
Neck Pain
Pallor
Palpitations
Pannus Formation
Formation, Pannus
Superficial vascularization of t
Paralysis
Paraplegia
Paralysis of the legs and lower
Paresis
A slight or incomplete paralysis
Patch Test, Abnormal Results Of
Patient Problem/Medical Prob Patient Problem Code|Patient Problem
Peak Expiratory Flowrate, De Decreased Peak Expiratory Fl A decrease of the greatest rate
Peak Expiratory Flowrate, Inc Flowrate, Increased Peak ExpiAn increase of the greatest rat
Peeling
A peeling off or loss of epiderm
Pelvic Inflammatory Disease Disease (PID), Pelvic InflammaAny pelvic infection involving
Perforation
Pericardial Effusion
Perinatal Brain Injury
Injury occurring as a result of
Peripheral Vascular Disease Disease, Peripheral Vascular|Vascular Disease, Peripheral
Peritoneal Laceration(s)
Laceration(s), Peritoneal
Peritonitis
Renal Failure
Reocclusion
Respiratory Acidosis
Respiratory Alkalosis
Respiratory Distress
Respiratory Distress Syndrom
Respiratory Failure
Respiratory Rate, Decreased
Respiratory Rate, Increased
Retina, Damage To
Retina, Degeneration Of
Retina, Tear(s) In
Rheumatic Heart Disease
Right Ventricular Dysfunction
Right Ventricular Failure
Right Ventricular Hypertrophy
Rupture
Scar Excision
Scar Tissue
Scarring
Scleroderma
Second-Degree Burn
Sedation
Seizures
Seizures, Absence
Seizures, Focal
Seizures, Focal Motor
Seizures, Grand-Mal
Sepsis
Seroma
Shaking/Tremors
Shock
Shock, Acoustic
Shock, Anaphylactic
Shock, Cardiogenic
Shock, Hypovolemic
Shock, Insulin
Shock, Neurogenic
Shock, Postoperative
Shock, Septic
Shock, Surgical
Shock, Traumatic
Sinus, Perforation Of
Sjogren's Syndrome
Skin Discoloration
Skin Erosion
Skin Inflammation
Skin Irritation
Skin Tears
Sleep Disturbances
Sneezing
Sore Throat
Spinal Cord Injury
Failure, Renal
Acidosis, Respiratory
Distress, Respiratory
Newborns (RDS), Respiratory A condition of the newborn mar
Failure, Respiratory
Decreased Respiratory Rate|Rate Of Respiration, Decreased
Increased Respiratory Rate|Rate Of Respiration, Increased
Damage To Retina
Degeneration Of Retina
Disease, Rheumatic Heart|Heart Disease, Rheumatic
Dysfunction, Right Ventricular
Failure, Right Ventricular|VentrFailure of proper functioning
Hypertrophy, Right Ventricular|Enlargement or overgrowth of t
Excision, Scar
Cicatrix|Tissue, Scar
Spinal Injury
Injury, Spinal
Sprain
ST Segment Depression
Depression, ST Segment
ST Segment Elevation
Elevation, ST Segment
Evaluation of the interval from
Stacking Breaths
Breaths, Stacking
Condition where there are a gr
Staphylococcus Aureus
S. aureus
Stenosis
Stricture
Narrowing or stricture of a duct
Stiffness, Neck
Neck Stiffness
Strangulation
Chocking or arrest of respirati
Sudden Cardiac Death
Cardiac Death, Sudden|Death, Sudden Cardiac
Suffocation
The stopping of respiration or t
Sunset Syndrome
Syndrome, Sunset
Decentration, or malposition of
Suture Abrasion
Sweating
Swelling
Swollen Glands
Glands, Swollen
Swollen Lymph Nodes
Lymph Nodes, Swollen|Nodes, Swollen Lymph
Syncope
Faint
Synovitis
Inflammation of a synovial m
Tachycardia
Heart Rate, Increased|Increased Heart Rate
Tearing, Excessive
Excessive Tearing
Teeth, Sensitivity Of
Sensitivity Of Tooth
Tentorial Tears
Tears, Tentorial
Pertaining to tears involving t
Teratogenic Effects
Effects, Teratogenic
Test Result
Therapeutic Effects, Unexpect Effects, Unexpected Therapeutic|Unexpected Therapeutic Effects
Therapeutic Response, Decre Decreased Therapeutic Response|Response, Decreased Therapeutic
Therapeutic Response, Increa Increased Therapeutic Response|Response, Increased Therapeutic
Third-Degree Burn
A full thickness burn that ext
Thromboembolism
Thrombosis
Thrombus
An aggregation of blood factors
Thyroid Problems
Problems, Thyroid
Tingling
A sensation as of repetitive pi
Tinnitus
Ears, Ringing In|Ringing In Ea A noise in the ears, such as rin
Tissue Breakdown
Tissue Damage
Damage, Tissue
Torsades-de-Pointes
Fringe of pointed tips; An atyp
Toxemia
The condition resulting from th
Toxic Shock Syndrome
Shock Syndrome (TSS), Toxic A severe illness caused by inf
Toxicity
Toxins In Children
Children, Toxins In
Children affected by toxins may be due to silicone breast imp
Toxoplasmosis, Acquired
Acquired Toxoplasmosis
Acquired as an adult.
Toxoplasmosis, Congenital
Congenital Toxoplasmosis
Passed from mother to fetus.
Transient Ischemic Attack
Attack, Transient Ischemic|Isc A brief attack (from a few minut
Tricuspid Insufficiency
Insufficiency, Tricuspid
Incomplete closure of the tricus
Tricuspid Regurgitation
Regurgitation, Tricuspid
The backflow of blood from the r
Tricuspid Stenosis
Stenosis, Tricuspid
Narrowing or stricture of the tri
Twiddlers Syndrome
Syndrome, Twiddler's
Dislodgement, breakdown, or oth
Twitching
The occurrence of a single cont
UGH (Uveitis-Glaucoma-Hyph Syndrome, Uveitis-Glaucoma For complications that occur se
Ulcer
Ulceration
Underdose
Uremia
Urinary Frequency
Frequency, Urinary
Urinary Retention
Retention, Urinary
Accumulation of urine within th
Urticaria
Hives
Urticaria.
Uterine Perforation
Perforation Of Uterus
Uveitis
Vaginal Discharge
Discharge, Vaginal
Vaginal Mucosa Damage
Damage, Vaginal Mucosa|Mucosa Damage, Vaginal
Valvular Stenosis
Vascular System (Circulation), Impaired Circulation
Vasoconstriction
Vasospasm
Vasodilatation
A state of increased caliber of
Vaso-Vagal Response
Venereal Disease
Disease (VD), Venereal|VD, V Any contagious disease acquire
Venipuncture
Ventilator Dependent
Dependent, Ventilator
Ventricle, Abnormality Of
Ventricular Fibrillation
Fibrillation, Ventricular
Arrhythmia characterized by fibr
Ventricular Flutter
Flutter, Ventricular
A ventricular tachyarrhythmia
Ventricular Tachycardia
An abnormally rapid ventricular
Vertigo
Vessel Or Plaque, Device Em Device Embedded In Vessel ODevice and/or fragments of device are embedded in patient's
Vessels, Perforation Of
Perforation Of Vessel(s)
Virus
Vision, Impaired
Impaired Vision
Vision, Loss Of
Loss Of Vision
Visual Disturbances
Disturbances, Visual
Vitrectomy
Vitreous Floaters
Floaters, Vitreous
Spots before the eyes; deposit
Vitreous Fluid, Blood In
Blood In Vitreous Fluid|Fluid, Blood In Vitreous
Vitreous Fluid, Loss Of
Fluid, Loss Of Vitreous|Loss Of Vitreous Fluid
Vitreous, Detachment Of
Detachment Of Vitreous
Vitritis
Inflammatory intraocular reactio
Vomiting
Weakness
Weight Fluctuations
Fluctuations Of Weight
Wheal(s)
Welt(s)
A smooth, slightly elevated are
Wound Dehiscence
Dehiscence Wound
Separation of the layers of a su
Wound Infection, Post-Operati Infection, Post-Operative Wound|Post-Operative Wound Infection
Wound Infection, Post-TraumaInfection, Post-Traumatic Wound|Post-Traumatic Wound Infection
Wrinkling
Zonular Dehiscence
NCIt Definition
Parent Concept's N Parent Concept'
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A filtering device designed to C49755
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A device designed to remove aiC49755
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A composite part of an air pumC49755
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Any of various types of bags d C49755
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A structure or object that imp C49755
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Mechanism
Device Component Or Accessory
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Detector
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Guide
Cannula
Cannula
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Monitor
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Pump
Device Component Or Accessory
Device Ingredient Or Reagent
Device Component Or Accessory
Coil
Device Component Or Accessory
Device Component Or Accessory
Pin
Lenses
Switches
Device Component Or Accessory
Device Component Or Accessory
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Computer Hardware
Computer Hardware
Device Component Or Accessory
Tube
Device Component Or Accessory
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Seal
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Cable
Device Component Or Accessory
Valve
Device Component Or Accessory
Unit
Device Component Or Accessory
Device Component Or Accessory
Device Subassembly
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Gauges/Meters
Device Component Or Accessory
Diagnostic, Therapeutic, Or Research Equipment
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
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Device Component Or Accessory
Device Component Or Accessory
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Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
PROM (Programmable Read Only Memory)
Device Component Or Accessory
Device Component Or Accessory
Filter
Device Component Or Accessory
Device Component Or Accessory
Fiberoptic
Device Component Or Accessory
Device Component Or Accessory
System
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
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Device Component Or Accessory
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Device Component Or Accessory
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Processor
Device Component Or Accessory
Device Component Or Accessory
Device Component Or Accessory
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Device Component Or Accessory
Device Component Or Accessory
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Device Component Or Accessory
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Function Indicator
Device Component Or Accessory
Device Component Or Accessory
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3049
3049
3049
3049
3049
3049
906
3049
3049
3049
3049
3049
3049
3049
877
3049
3049
3049
3049
3049
462
3049
3049
3049
832
3049
3049
3049
432
816
918
3049
3049
3049
3049
3049
555
3049
3049
3049
927
3049
3049
3049
943
3049
3049
431
3049
3049
3028
3049
3049
3049
462
3049
462
3049
3049
3049
3085
3049
3049
3049
430
3049
486
3049
3049
527
3049
3049
3049
3049
3049
3049
3049
3049
519
3049
3049
3049
3049
3049
3049
3049
3049
462
3049
3049
3049
3049
3049
3049
3127
3049
918
510
3049
3049
3049
3049
3049
3049
430
462
3049
3049
3049
3049
3049
761
3095
435
3049
3049
3049
3049
3049
3049
3049
3049
3049
3049
3049
3049
3049
3049
525
3049
3049
848
3049
3049
527
527
527
527
527
527
527
527
527
527
527
527
527
527
527
3049
3049
3049
3049
3049
462
3049
3116
829
816
3049
3049
3049
3130
3049
3049
3049
3049
435
C91894
ergoing an evaluation but has not yet been C54030
m was traced back to the design specificatioC91885
ncluding set-up, operation, and disassembl C91874
C91894
hat occurred in part or in total related to th C91874
orrectly modified or prepared for use by distr
C91874
C91894
C91894
C91894
C91894
paired and returned to the user (reporter) f C91885
C62596
elated to the user not following the manufac
C91874
C54030
C91894
elated to problems with the underlying framC54030
nown and documented in the labeling (incluC54030
hat occur as the result of problems with the C54030
hat result from improper routine or prevent C91885
m was traced back to the manufacture of thC91885
C91894
C91894
elated to its use during an unapproved proced
C54030
elated to the operator's technique or use C91874
cesses or systems used in the design and C54030
elated to the use of a device more than oncC54030
elated to inadequate training.
C54030
aint or problem cannot be confirmed. If possiC54030
ween the device and the user caused or cont
C91874
for its response to variations in air pressu C91963
s response to variations in air pressure fo C91898
C54028
C54028
for the presence of chemicals or other age C91912
ice for characteristics that may cause bloodC91938
A record of data captured aboutC91993
w of the assembly and packaging processes
C91978
cts of a substance on a living organism. Bi C91905
to determine if it elicits an undesirable localC91905
C54028
s ability to promote cancer or facilitate its C91934
e's characteristics that may affect cells.
C92015
w of source code intended to find and fix mC91993
mon error patterns and violations of best p C91995
e's ability to activate the process of clear C91938
to determine if the correct combination of mC91961
for problems that can occur as the result o C92005
of a device's conducted emissions to causeC91925
to detect the presence of any substance thC91905
s ability to withstand a constant tensile lo C92005
he amount of electricity leakage from the d C91919
used and generated by a program is corre C91993
67
17
25
19
67
19
19
67
67
67
67
25
19
17
67
17
17
17
25
25
67
67
17
19
17
17
17
17
19
26
3261
3291
3291
3277
3298
22
3331
3269
3269
3291
3294
3364
22
3347
3298
3318
3355
3289
3269
3355
23
22
3318
3347
3263
3263
3263
3318
20
20
3355
3291
3301
3301
3291
3321
3301
3286
3291
3355
26
26
3355
3269
3336
3364
3355
3269
3290
3337
38
3286
3355
23
3367
3261
26
3331
23
3269
3291
3337
3291
3291
3290
23
3337
3337
3331
3331
3277
3291
3291
3277
Stress Testing
Mechanical Evaluation
Mechanical Evaluation
Stress Testing
Biologic Evaluation
Radiographic Inspection
Tissue Engineering Evaluation
Stress Testing
Biologic Evaluation
Environment Evaluation
Radiologic Evaluation
Visual Inspection
Electromagnetic Compatibility (EMC) Evaluation
Stress Testing
Electrical Evaluation
Use Testing
Acoustic Energy Testing
Mechanical Evaluation
Process Evaluation
Electrical Evaluation
Biologic Evaluation
Evaluation Method
Radiologic Evaluation
Evaluation Method
Evaluation Method
Environment Evaluation
Electrical Evaluation
Radiologic Evaluation
Radiologic Evaluation
Process Evaluation
Process Evaluation
Contamination Testing
Evaluation Method
Evaluation Method
Contamination Testing
C92023
C91934
C91897
C91965
C91919
C92002
C91905
C91941
for problems related to the incorrect or i C91961
for characteristics that lead to the activa C91938
verify a device's level of protection (immu C91942
sources in a device e.g., battery, internal C91919
s characteristics when subjected to high or C91926
w of the manufacturing and production proce
C54028
w of the processes used in developing sys C91978
of a device's radiated emissions to cause C91925
magnetic field gradients on medical imagingC91983
d
to detect device malfunctions caused by a di
C91942
C91941
ety provisions in a device used for medical iC91919
for problems related to how the materials reC91961
e for chemicals or other agents that may h C91905
C91932
C91932
e's characteristics for its affects on the rep C92015
cts or surfaces requiring magnification us C91965
e for problems resulting from transient physC92005
s in situations that mimic real life settings b C92020
C54028
o evaluate a software application at or beyonC91996
ystem or component during or at the end o C91993
verify that a system or component performsC91993
using a spectrometer or spectrograph for thC92023
alyzing the software code without running itC91996
methods used to free a medical device fromC92002
w of the records and processes used to re C91978
w of the storage and shipping processes a C91978
s ability to resist forces that attempt to br C92005
for failures caused by applying force per uniC91963
s ability to protect itself of other devices
C91942
nse to a transient electrical current or volt C91919
n a complete, integrated system to evaluateC91996
s characteristics when subjected to temperC91926
C92013
C92013
for conditions related to extremes of tempeC54028
for characteristics related to forming bloo C91938
e's characteristics that may affect tissues ( C91905
s response to variations in air pressure fo C91898
al hardware or software components or grouC91996
med that simulates real use situations expe C91951
defined group of users about their practice C92020
e for problems resulting from periodic or C92005
38
3294
3263
3321
23
3352
3269
3300
3318
3298
3301
23
3290
3291
3331
3289
3337
3301
3300
23
3318
3269
12
12
3364
3321
3355
3367
3291
3348
22
22
38
3348
3352
3331
3331
3355
26
3301
23
3348
3290
3362
3362
3291
3298
3269
3261
3348
20
3367
3355
Visual Inspection
Genotoxic Testing
Actual Device Not Evaluated
Microscopic Inspection
Electrical Evaluation
Sterilization Process Review
Biologic Evaluation
Image Inspection
Materials And Chemistry Evaluation
Hematologic Testing
Immunity Testing
Electrical Evaluation
Environment Evaluation
Evaluation Method
Process Evaluation
Emissions Testing
Radiologic Evaluation
Immunity Testing
Image Inspection
Electrical Evaluation
Materials And Chemistry Evaluation
Biologic Evaluation
Device From Reserve Sample Evaluated
Device From Reserve Sample Evaluated
Tissue Engineering Evaluation
Microscopic Inspection
Stress Testing
Use Testing
Evaluation Method
Software Verification
Software Evaluation
Software Evaluation
Visual Inspection
Software Verification
Sterilization Process Review
Process Evaluation
Process Evaluation
Stress Testing
Mechanical Evaluation
Immunity Testing
Electrical Evaluation
Software Verification
Environment Evaluation
Thermal Energy Evaluation
Thermal Energy Evaluation
Evaluation Method
Hematologic Testing
Biologic Evaluation
Acoustic Energy Testing
Software Verification
Interoperability Evaluation
Use Testing
Stress Testing
C54028
for its immunity when subjected to positive C91919
e for signs of unexpected erosion on its su C92005
the ability of the blood to clot which may C92060
re performed an incorrect arithmetic operat C92115
hat occurred because the device was assem
C92076
cellular or tissue responses that elicit an uC92030
C54029
y to promote cancer or facilitate its propagaC92057
hat occurred during or as the result of the clC92076
t send or receive adequate signals (this sp C92070
es with an organism's ability to clear pat C92060
ponent of a device that has moved from its o
C92079
rienced electromagnetic interference (EMI) C92046
ue to incorrect version or change control. C92113
resence of any substance that does not belo
C92030
riences problems related to small currents C92097
rienced damage as the result of a chemicalC92033
orrupted during the operation of reducing C92042
re locked up because two or more processes
C92115
aused by changes in the shape or size of the
C92120
hat occur when the device becomes worn, w
C92078
ponent had faulty (incomplete or incorrect) C92113
rienced problems due to dust or dirt that haC92051
C54029
or device-environment problem resulting C54029
rienced problems due to sudden and momentar
C92046
hat occur from its reaching the end of its use
C92088
resence of toxins associated with certain baC92054
elated to the energy storage system (e.g. C92097
hat occurred due to factors within the envirC54029
C62596
ot calibrate (establish the relationship be C92088
ue to the weakening or breakdown of its mat
C92120
aused by the separation of a component, obj
C92120
caused by its surface coming in contact withC92079
y to cause damage to genetic material (e. C92030
hat result from the gradient induced fields C92102
ults from improper sequencing or activatio C92045
or impacts the blood or its components. C92030
distortion of an image due to signal loss C92102
rienced problems due to insufficient or exces
C92045
ssociated with the improper combination ofC92065
m
unctions as the result of exposure to undesiC92051
hat occur due to the presence of a material C92078
elated to the incorrect or inadequate arra C92065
unctions as the result of exposure to the te C92051
adequate immunity or capabilities to resis C92046
ation on the labels or in the manuals relatedC92071
or inappropriate information on the labels C92071
ation of a device possibly resulting in th
C92033
unctions due to a component(s) that does no
C92070
elated to materials that can co-exist simultaC92078
3291
23
3355
3255
3240
170
3204
3249
3254
170
3213
3255
180
197
104
3204
3227
201
110
3240
3243
174
104
331
3249
3249
197
114
142
3227
3249
Evaluation Method
Electrical Evaluation
Stress Testing
Hematologic Problem
Software Runtime Error
Manufacturing Process Problem
Biological Problem
Evaluation Result
Genotoxic Problem
Manufacturing Process Problem
Interoperability Problem
Hematologic Problem
Mechanical Problem
Electromagnetic Compatibility Problem
Software Problem
Biological Problem
Power Source Problem
Cleaning, Disinfecting And Sterilization Problem
Design Error
Software Runtime Error
Stress Problem
Materials And Chemistry Problem
Software Problem
Environment Problem
Evaluation Result
Evaluation Result
Electromagnetic Compatibility Problem
Operational Problem
Contamination By Foreign Material
Power Source Problem
Evaluation Result
114
3243
3243
180
3204
3230
120
3204
3230
120
202
331
174
202
331
197
150
150
201
3213
174
Operational Problem
Stress Problem
Stress Problem
Mechanical Problem
Biological Problem
Radiographic Problem
Electrical Problem
Biological Problem
Radiographic Problem
Electrical Problem
Improper Material
Environment Problem
Materials And Chemistry Problem
Improper Material
Environment Problem
Electromagnetic Compatibility Problem
Labeling Problem
Labeling Problem
Cleaning, Disinfecting And Sterilization Problem
Interoperability Problem
Materials And Chemistry Problem
3249
110
110
170
120
110
3249
3249
3240
3227
180
3230
170
3249
142
3249
3249
3243
142
202
3254
3249
3249
110
3240
120
3249
3249
3224
3240
111
111
170
3255
3227
120
120
170
3230
197
120
174
3204
3249
201
3240
114
170
120
120
104
3249
104
Evaluation Result
Design Error
Design Error
Manufacturing Process Problem
Electrical Problem
Design Error
Evaluation Result
Evaluation Result
Software Runtime Error
Power Source Problem
Mechanical Problem
Radiographic Problem
Manufacturing Process Problem
Evaluation Result
Contamination By Foreign Material
Evaluation Result
Evaluation Result
Stress Problem
Contamination By Foreign Material
Improper Material
Genotoxic Problem
Evaluation Result
Evaluation Result
Design Error
Software Runtime Error
Electrical Problem
Evaluation Result
Evaluation Result
Optical Problem
Software Runtime Error
Packaging Problem
Packaging Problem
Manufacturing Process Problem
Hematologic Problem
Power Source Problem
Electrical Problem
Electrical Problem
Manufacturing Process Problem
Radiographic Problem
Electromagnetic Compatibility Problem
Electrical Problem
Materials And Chemistry Problem
Biological Problem
Evaluation Result
Cleaning, Disinfecting And Sterilization Problem
Software Runtime Error
Operational Problem
Manufacturing Process Problem
Electrical Problem
Electrical Problem
Software Problem
Evaluation Result
Software Problem
104
104
110
180
170
180
3249
3255
114
3240
3240
3240
111
3243
3243
628
628
2892
2897
2946
2951
2929
2929
2880
1112
1112
2880
3025
2928
2583
2583
2456
2170
2908
2885
3010
2981
2910
2303
2929
2954
1423
2900
2978
2978
3022
2978
1153
2440
2914
1089
1198
2878
Software Problem
Software Problem
Design Error
Mechanical Problem
Manufacturing Process Problem
Mechanical Problem
Evaluation Result
Hematologic Problem
Operational Problem
Software Runtime Error
Software Runtime Error
Software Runtime Error
Packaging Problem
Stress Problem
Stress Problem
Communications Problem
Communications Problem
Charging Issue
Component Or Accessory Incompatibility
Gas Leak
Improper Alarm
Environmental Control Or Utility Issue
Environmental Control Or Utility Issue
Application Program Issue
Computer Software Issue
Computer Software Issue
Application Program Issue
Unauthorized Access To Computer System
Electronic Property Issue
Arcing
Arcing
Incorrect Or Inadequate Test Results
Suction Issue
Device Contamination With Biological Material
Battery Issue
Power Source Issue
Material Twisted
Device Ingredient Or Reagent Issue
Bacterial Contamination Of Device
Environmental Control Or Utility Issue
Improper Flow Or Infusion
Occlusion Within Device
Connection Issue
Material Integrity Issue
Material Integrity Issue
Temperature Issue
Material Integrity Issue
Degraded
Failure To Calibrate
Device Operational Issue
Circuit Failure
Electrical Issue
Ambient Temperature Issue
C63025
C63286
with any deviations from device documentedC62937
with unintentional pouring out or releasing C62945
with a failure of the internal network paths orC63005
with the aggregation of particles into irregu C62845
with the undesired characterization of congeal
C62845
C62962
with the buckling or crushing of material fro C62923
with the device sending or receiving signal C62937
with an undesirable descent of a device compo
C62950
C63020
with the absence of any part, substance, softC63041
with the incompatibility of any device and C62983
with the machinery operating system, a coll C63269
Issue associated with written C62954
C63269
with linking of device and/or device component
C62954
with the undesired introduction of impurities C63276
e
C63018
with the excessive production of electrical i C63007
with the chemical or electrochemical reactioC62970
with an undesired separation and/or a visibleC62968
with the degree to which an antibody or antigC62845
C62967
with problems relating to a system, component
C63269
Incorrect transfer, storage, dis C63305
with programming of calendar dates and/or tiC63269
with the device and/or device components be
C62952
C62934
with the removal by suction of excess fluid oC62833
C62860
ce being less sensitive to an input than in C63061
C63112
with a device component having flaws of dimC63250
with having flaws or dimensional deviations C63041
with the inability of device and/or device co C63075
with a deleterious change in the chemical strC62968
with peeling of composite materials. Occurs C62878
C63112
with an unexpected amount of time requiredC63026
t
with the device being received in such a manC63019
C62961
C63248
with any deviations from device documentedC62954
p
with the unintentional separation of the dev C63242
ED WITH THE SEPARATION OF THE DE C62961
C62846
with electrical equipment or a system that d C62932
with the insufficient removal of unwanted visC63276
C62896
C63018
C63017
3010
1071
3008
2893
2928
3021
3021
2981
2506
3008
2923
2897
2975
2960
1112
2914
1112
2914
2895
1120
1198
1153
2978
3021
2205
1112
2880
1112
2900
3012
2170
3016
2293
2951
2588
2975
2964
2978
1454
2951
2892
2969
1384
2976
2914
2907
1384
3020
3015
2895
1423
1120
2908
C63041
C76121
with the use of the device in terms of user exC76121
C63099
with a device prompting user with an error C62955
C62945
with the expiration date or shelf life of a pro C63209
n accordance with specification.
C63318
C62945
with the device being in a nonfunctional or C63007
An adverse event and reportablC62596
with the servicing of a device.
C62808
with the written, printed or graphic material C63041
C63041
with any deviations from expected performaC62954
with any deviations from specifications relat C62996
with one device and/or device component c C62961
C62950
with the non-conformance to device specifi C62939
with the device continuing to be in an active C62988
C63099
with device features that are designed to resC63007
with any deviation from device document speci
C62955
C63209
with the incompatibility of two or more dev C62983
C63244
with difficulty moving the device or its compoC63034
with users experiencing difficulty or uneasi C63013
C62896
with the use of the device in terms of user exC62923
with problems introducing or inserting the dev
C63034
with difficulty of a transponder system to tr C63173
with the use of the device in terms of user e C62923
with difficulty for end-users to operate devic C62939
with the use of the device in terms of user e C63034
with the user's ability to cause device settin C76121
with the use of the device in terms of user e C63034
C63242
with the linking of device and/or device com C62952
with the undesired introduction of impurities C62808
with mechanical force that displaces devic C62961
with not correctly reading the patient or test C62848
C63081
C62948
with a failure of the electrical circuitry or c C62954
with an electrical activity that exceeded the sp
C63005
with the quality of the facility-supplied powerC63209
C63277
with the ability of a system to function in it C63005
with a measure of electromagnetic radiatio C63215
with any deviations from device documentedC62937
pe
with the discharge of electricity between twoC63215
with the failure of the facility's emergency C63217
2975
2949
2949
1091
2913
2893
2929
1670
2893
1198
2935
2975
2975
2914
2379
1384
2923
3007
2939
1091
1198
2913
2929
2960
1157
3009
2906
1423
2506
3009
1332
2506
3007
3009
2949
3009
2907
2900
2935
1384
1535
1495
1506
2914
2928
2929
1089
2928
2927
3008
2927
2925
Facilities Issue
Manufacturing Or Shipping Issue Associated With Device
Manufacturing Or Shipping Issue Associated With Device
Device Operational Issue
Device Issue
Mechanical Issue
Dislodged Or Dislocated
Packaging Issue
Failure To Shut Off
Device Cleaning Issue
Electrical Issue
Device Operates Differently Than Expected
Environmental Control Or Utility Issue
Incompatibility Problem
Difficult To Deploy
Positioning Issue
Deployment Issue
Occlusion Within Device
Structural Problem
Positioning Issue
Failure To Interrogate
Structural Problem
Packaging Issue
Positioning Issue
Human-Device Interface Issue
Positioning Issue
Detachment Of Device Or Device Component
Connection Issue
Facilities Issue
Mechanical Issue
Incorrect Or Inadequate Result
Incorrect Software Programming Calculations
Product Quality Issue
Device Operational Issue
Electronic Property Issue
Environmental Control Or Utility Issue
Circuit Failure
Electronic Property Issue
Electromagnetic Compatibility Issue
Physical Property Issue
Electromagnetic Compatibility Issue
Electrical Power Problem
C63002
C63002
with the device and/or device accessories caC63034
with the surrounding conditions in which the C62808
with fine solids or liquid particles such as C63209
C63088
C62950
C63075
with the device or its components producingC62922
with errors in identification of expiration dateC62998
with the unintended ejection of device compC62917
with the unintended of projection of device C62917
with the physical establishment and environm
C62996
with safety features malfunctioning in such aC62997
C62932
with the device failing to perform an interna C62997
with difficulties in attaching a device to an C62955
with failure to move the device or its compo C63034
with a circuit, equipment, or system wherebyC62960
i
Analyze|Rhythm, Failure To Diagnose
C63061
with the inability of a device to turn itself o C62932
with the inability to backup or to retrieve a C63258
with the failure of the device to perform a C63028
with the failure to achieve effective and consC63027
with inability to initiate the appropriate cha C63026
with the inability of a device and/or device c C63007
therapy or set of therapies to terminate th C63007
C63258
C62960
with the device failing to complete a series C62960
C62902
with the effective electromotive force withinC63158
C63002
with the inability of device and/or device co C63013
with the failure of a battery or other charge C63158
with the linking of device and/or device com C62952
C63008
with the device or one of its components fai C63013
with a therapy or algorithm not being delive C62955
C63107
C63248
C62960
C62902
with the device failure to appropriately resp C63007
C62955
with the failure to see direct anchorage of a C62886
with the inability of device and/or device c C63007
C63025
C62955
C62860
C63271
C62994
C63107
1431
1431
3009
2935
2929
1184
2923
2964
3022
1216
1395
1395
2379
2936
3015
2936
2913
3009
2984
2293
3015
2902
2890
2891
2892
1198
1198
2902
2984
2984
2991
1573
1431
2906
1573
2900
2909
2906
2913
2309
2976
2984
2991
1198
2913
3003
1198
3010
2913
3016
2896
2440
2309
C62852
C62992
C63030
C63061
with the failure of a device designed to resp C63238
with the device or one of its components fai C63013
with the lack of periodic preventive maint C62977
with the inability of device and/or device co C63007
with the device not powering off when a sh C63005
o generate a correctly-shaped pacing outpuC63169
C63008
C63271
with the comprising materials' deformation inC63248
with problems removing the materials used tC63231
C62852
with device providing incorrect alarm warningC63033
C63108
with the device incorrectly reporting that s C62848
with the device incorrectly reporting that s C62848
with the non-compliance of the device to mee
C62848
with the method or amount of time associated
C63075
with the process of passing a substance throC63075
with the combustion of device components,C62922
r
with the connection of device and/or device cC62952
with the detachment of small pieces of the co
C62970
with device-related burn with an unsteady f C62922
with approaching certain temperatures at whiC62945
C63058
with the visibility of water vapor in the imm C62807
C63296
with the presence of materials, which are n C63018
with any structural discontinuity in the materia
C62973
with uncontrolled flow of infusion of air, gas oC63110
with the visibility, odor, or toxicity of an am C62807
with the visibility of molds, mildews, yeast C63292
with the unintended escape of a gas from the
C63058
C63058
with the increased rate of change in temperat
C63110
with the inability to connect conductors of a C63007
C64334
with the amount of output energy needed to C63027
with higher than intended electrical imped C63114
C62982
C62848
with the amount of input required by the devC63061
C62829
with an opening not characteristic of the norC62967
C63137
with the interaction and interfacing between C62996
C63118
asurement functions produce erroneous resu
C63088
with an incorrect image orientation on the deC63108
C62869
3019
1476
2885
2293
2917
2906
1379
1198
2928
1439
2909
2896
2976
2922
3019
1012
2953
1535
1535
1535
2964
2964
3022
2900
1153
3022
2893
1354
3027
1059
1120
1069
2954
3027
2887
1354
1354
2954
1198
2884
2891
2950
2910
1535
2293
2456
2205
1250
2379
2948
1184
2953
1408
Reset Issue
Failure To Power-Up
Battery Issue
Invalid Sensing
Device Sensing Issue
Deployment Issue
Device Maintenance Issue
Electrical Issue
Electronic Property Issue
Failure To Pace Or Properly Pace
Device Disinfection Or Sterilization Issue
Communication Or Transmission Issue
Material Deformation
Difficult To Open Or Remove Packaging Material
Reset Issue
Device Alarm System Issue
Improper Device Output
Incorrect Or Inadequate Result
Incorrect Or Inadequate Result
Incorrect Or Inadequate Result
Infusion Or Flow Issue
Infusion Or Flow Issue
Temperature Issue
Connection Issue
Degraded
Temperature Issue
Chemical Issue
Leak
Ventilation Issue In Device Environment
Bent
Contamination During Use
Break
Improper Flow Or Infusion
Ventilation Issue In Device Environment
Biological Environmental Factor
Leak
Leak
Improper Flow Or Infusion
Electrical Issue
Battery Impedance Issue
Capturing Issue
Impedance Issue
Device Ingredient Or Reagent Issue
Incorrect Or Inadequate Result
Invalid Sensing
Incorrect Or Inadequate Test Results
Material Perforation
Fluid Leak
Device Issue
Human Factors Issue
Incorrect Display
Improper Device Output
Poor Quality Image
C62887
with electrical impedance levels between d C63005
C62994
C63033
with an unexpected or inappropriate chemical
C62945
with the inaccurate outcome of a measureme
C62941
with the unsubstantiated regulation and delive
C63075
C63108
with the use of the device in terms of non-c C63318
C63144
C62902
C63110
C63104
C63110
with an error due to imperfect timing of two C63169
C62986
with inaccuracies in any written, printed, or C63072
with users being unclear and not able to foll C63072
with an inappropriate level of light or illum C63209
with inadequate periodic preventive maint C62977
with inadequate or inappropriate storage of C62808
th facility not providing satisfactory initial C63118
with the means by which the operator and t C76121
with the inability to appropriately perform o C62852
C63108
with the inappropriate delivery of an electric C63158
C63094
with the device not being compatible with anC62954
with the heart valve leaflet not closing propeC62923
C63240
with the delivery of an inappropriate device C63041
with device failure and malfunction when deC63108
C63305
C63061
C62848
with a non-conforming end result, data, or teC62941
C62848
C62839
C62934
on, Increase In
C62833
C62860
ce being more sensitive to an input than i C63061
with the inability of a device and/or device c C63075
with the device failing to deliver liquids or g C62954
with unsatisfactory installation, configuratio C62808
with the accuracy and appropriateness of any
C63118
with device or device parts being insufficie C62922
with an underdose of intravenous therapy, i.C63075
with the device or its components producingC62922
with the ineffective and inconsistent depolariC63027
C63277
C63110
with the failure to deliver shock for a limited C63158
1305
2928
2440
1012
2893
3005
2964
2953
1670
1233
2991
2954
2339
2954
1439
2941
1318
1318
2929
1379
2935
2948
2949
3019
2953
1573
2280
2914
2506
2916
2975
2953
2880
2293
1535
3005
1535
3014
3012
2170
3016
2293
2964
2914
2935
2948
3022
2964
3022
2891
1089
2954
1573
2917
1184
2975
1059
2981
1379
1384
3001
2983
2900
3196
1069
3003
2925
2293
2951
2885
2884
2950
1535
2293
2456
1379
3009
3008
2978
2978
2978
2978
1153
1069
2976
3008
2976
2978
2978
2978
2205
2976
2205
2978
2981
2976
2960
3008
1384
1384
2929
3014
2976
1177
3026
2913
C63318
with the connection of device and/or device C62952
with failure of device to discharge its load (e.C62961
C62891
with the results of a test or measurement n C62829
A specific reason explaining w C62596
with damage inflicted upon the device or d C62909
with an unsatisfactory humidity level in the C63209
C63248
with material damage to a surface, usually i C62970
C48655
with no measurement outcome, value, or datC62941
with the absence of visual indicator.
C62900
C62997
the device failing to deliver the specified li C63075
Information regarding the subjeC48655
C48655
with the device ceasing to deliver paces.
C63169
C62934
C63094
An unintended or unpleasant sC62961
with a material that does not meet the specifC62948
Determination of a value is notC48655
C63112
C63075
with an obstruction or blockage within any ofC62897
with malfunction of the computer operating C63270
with replacing an older operation system to C63270
with being off-center of optical lenses.
C62953
with an optical streak or other pattern on th C62953
with an optical defect in an image-forming C62953
with problems transmitting visible light affectC62937
with the blocking of optical devices, e.g., vi C62953
with interconnection between bone tissue a C62961
C62948
C63108
C63108
C63108
with any deviation from device documented C62954
pe
with an adjustment that surpasses a set crit C63028
C63144
with the device producing high temperaturesC62922
C63061
C63169
with a pacing transmission process such thatC63169
pulse width is less than desired.
C63169
with the failure of pacing device for a limitedC63169
with the materials used to construct the cov C63041
C63081
onsist of separate particles that are introd C62845
The retrieval of incorrect data C91397
with the interaction between the patient's phC62983
with stresses of sufficient magnitude to excee
C62970
1670
2900
1384
1360
2456
2986
2929
2976
1153
3192
3005
1435
2936
2964
3192
3192
1439
3012
2280
1384
1506
3192
2951
2964
2423
2898
2898
3001
3001
3001
3008
3001
1384
1506
2953
2953
2953
2914
2890
1233
3022
2293
1439
1439
1439
1439
2975
1495
3021
3196
2960
1153
1250
2379
3009
1153
2938
1442
2953
1384
1495
2925
1198
3016
3021
2906
2885
3011
3011
3015
2964
2880
2975
2880
2913
2914
2964
3016
1354
1432
3004
2896
2927
2954
2682
3015
1091
2954
1384
2978
2910
2906
2293
1216
3015
2284
1233
2682
2923
3022
1068
2928
2978
3009
2976
Fluid Leak
Device Issue
Positioning Issue
Degraded
Failure To Auto Stop
Pacing Inadequately
Improper Device Output
Mechanical Issue
Incorrect Software Programming Calculations
Electrical Power Problem
Electrical Issue
Pumping Issue
Sediment, Precipitate Or Deposit In Device Or Device Ing
Deployment Issue
Battery Issue
Premature Indicator Activation
Premature Indicator Activation
Protective Measure Issue
Infusion Or Flow Issue
Application Program Issue
Manufacturing Or Shipping Issue Associated With Device
Application Program Issue
Device Operates Differently Than Expected
Device Operational Issue
Infusion Or Flow Issue
Pumping Issue
Leak
Output Above Specifications
Output Below Specifications
Communication Or Transmission Issue
Electromagnetic Compatibility Issue
Improper Flow Or Infusion
Patient-Device Incompatibility
Protective Measure Issue
Device Cleaning Issue
Improper Flow Or Infusion
Mechanical Issue
Material Integrity Issue
Device Ingredient Or Reagent Issue
Deployment Issue
Invalid Sensing
Device Expiration Issue
Protective Measure Issue
Device Damaged Prior To Use
Filling Problem
Patient-Device Incompatibility
Dislodged Or Dislocated
Temperature Issue
Loss Of Or Failure To Bond
Electronic Property Issue
Material Integrity Issue
Positioning Issue
Material Deformation
C63137
with the basic physical construction or phys C62961
with suction equipment, which may be a manu
C63075
C63240
with variability of the transmission of sign C63271
with the device producing unintended tempeC62937
with the failure of the device to deliver any eC63108
with the device causing unintended therapeut
C62955
with the amount of gas that is inspired and eC63110
C63043
with comprising material(s) being pulled aparC62968
with the transfer of fluid between the bloo C62986
C63088
with an access that was not permitted to theC64348
C62962
C63061
with the use of a medical device for therape C62848
C62814
with device or device components impactingC62814
with unexpected discharge of device from expe
C62955
vice Energization
C63025
C62814
C62883
Movement of a medical device C62961
t
with any motion of the system or components
C62814
C62970
C63240
with the connection of device and/or device C62814
unt of output energy needed to cause cardiC63027
with user's failure to process, service, or
C63118
with the use of the device in terms of inappr C63318
C63318
C63209
with an oscillation wherein the quantity is C62814
C63144
Any issue that impedes communi
C63271
C63296
An involuntary muscular contraC34827
Any termination of pregnancy hC54027
Expulsion of all the products C35221
The uterus is not entirely emp C35221
Abortion brought on intentionalC35221
Retention in uterus of an abortC35221
Superficial damage to the skin C3671
An inflammatory process charact
C2890
Failure of the smooth muscle fib
C54027
Injury to the hearing mechanis C54027
A fibrous band of tissue that C54027
Progressive and life-threateni C54027
A syndrome resulting from the C54027
The presence of bubbles of airC26759
C54027
C54027
1250
1384
2964
2916
2896
3008
2953
2913
2954
2616
2978
2941
1184
2899
2981
2293
1535
3026
3026
2913
3010
3026
1437
1384
3026
1153
2916
3026
2891
2948
1670
1670
2929
3026
1233
2896
1059
2193
2688
1688
1688
1688
1688
2348
1735
2688
2688
2688
2688
2688
1829
2688
2688
Fluid Leak
Mechanical Issue
Infusion Or Flow Issue
Device Packaging Compromised
Communication Or Transmission Issue
Physical Property Issue
Improper Device Output
Device Operates Differently Than Expected
Improper Flow Or Infusion
Malposition Of Device
Material Integrity Issue
Filtration Issue
Incorrect Display
Computer System Security Issue
Material Twisted
Invalid Sensing
Incorrect Or Inadequate Result
Unintended Movement
Unintended Movement
Device Operates Differently Than Expected
Power Source Issue
Unintended Movement
Overheating Of Device Or Device Component
Mechanical Issue
Unintended Movement
Degraded
Device Packaging Compromised
Unintended Movement
Capturing Issue
Human Factors Issue
Use Of Device Issue
Use Of Device Issue
Environmental Control Or Utility Issue
Unintended Movement
Filling Problem
Communication Or Transmission Issue
Bent
Cramp(s)
Patient Problem/Medical Problem
Abortion
Abortion
Abortion
Abortion
Injury
Infection, Bacterial
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Embolism
Patient Problem/Medical Problem
Patient Problem/Medical Problem
C54027
Inflammation of the amnion. C54027
Resembling anaphylaxis.
C54027
A peripheral (mature) T-cell ly C3208
C54027
A reduction in the number of r C54027
chy Or Insufficient Anesthesia|Patchy, LighC54027
Bulging or ballooning in an areC54027
Paroxysms of chest pain due t C54027
Absence or reduction of oxygenC3890
C25637
Apprehension of danger and dre
C54027
A progressive tear in the tissu C54027
Dysfunction of the aortic valve C50796
The backward flow of blood from
C51223
Narrowing of the orifice of the C62433
ed Apgar Score|Score, Decreased Or Low C54027
A procedure that collects a comC54027
Excision of the apex of the pet C54027
Transient cessation of respirat C54027
A chronic adhesive arachnoiditC54027
Any variation from the normal C54027
A vascular disorder characterizC54027
Pain in a joint.
C3303
An inflammatory process affec C35760
A chronic, systemic autoimmune
C2883
Accumulation of fluid in the pe C54027
A state of general hypoxia and C3890
The entry of foreign material C54027
A chronic respiratory disease C54027
Build-up of fatty material and cC34398
A disorder characterized by anC54027
A disorder characterized by an C54027
C54027
A disorder characterized by anC54027
A disorder resulting from loss C54027
A specific humoral or cell-me C54027
Cirrhosis of the liver caused ei C54027
C54027
nts, Abnormal Blood Gas
C54027
Loss of blood from the circulatio
C54027
Blurred vision is the loss of vi C54027
A rupture in the wall of the sm C4080
An abnormally slow heart rate. C54027
C54027
A mass in the mammary gland,C54027
e
A benign or malignant neoplas C54027
An acute or chronic inflammatoC54027
Acute inflammation of the wallsC3333
Sudden contraction of the smoo
C54027
Injury of the soft tissues or b C3671
A traumatic injury involving in C3671
C34441
2688
2688
2688
3263
2688
2688
2688
2688
2688
1918
2414
2688
2688
1926
1715
2697
2688
2688
2688
2688
2688
2688
2688
1994
2373
1723
2688
1918
2688
2688
1722
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2001
2688
2688
2688
2688
2688
2011
2688
2348
2348
1757
C34441
A burn injury caused by heat orC34441
A sensation of stinging or heat C54027
Deposition of calcium in the ti C9442
A tumor composed of atypical C54027
A carcinoma arising from the bC9305
C54027
The tightening of scar tissue t C54027
The sudden cessation of cardiaC54027
The presence of an acquired hC54027
Acute compression of the heartC54027
A disease of the heart muscle oC54027
Cessation of breathing and/or C54027
Partial or complete opacity of C54027
A cataract that has been produce
C26713
A burn caused by exposure to C34441
Inflammation of the dermis an C2890
A subperiosteal hemorrhage limC54027
C50448
The loss of cerebrospinal fluid C54027
A sudden loss of neurological C54027
abnormal, pathological, benign, malignant, C54027
C54027
Edema of the mucous membrane
C3002
Pain in the chest.
C3303
C54027
Shivering or moderate tremorsC54027
A condition caused by blockingC3671
A morphologic finding indicatinC54027
A chronic and progressive lungC54027
C54027
C54027
he central region of the cornea, usually as C54027
A condition in which there is a C54027
aracterized by cognition. That operation o C54027
C54027
A state of profound unconsciouC54027
C54027
A disorder characterized by an C54027
A violent jar or shock, or the c C3671
A mental state characterized b C54027
Any abnormality, anatomical orC54027
Failure of the heart to pump a C54027
Inflammation of the conjunctivaC54027
A congenital or acquired disor C54027
Irregular and infrequent or diff C54027
A bruise due to trauma.
C3671
A convulsion marked by alternaC54027
Prolonged contraction of the mu
C54027
C54027
Injury to the epithelium of the C54027
Endothelial decompensation tha
C54027
Hazy, swollen cornea.
C3002
1757
1757
2688
1809
2688
3262
2688
2688
2688
2688
2688
2688
2688
2688
1766
1757
1735
2688
2078
2688
2688
2688
2688
1820
1994
2688
2688
2348
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2348
2688
2688
2688
2688
2688
2688
2348
2688
2688
2688
2688
2688
1820
Burn(s)
Burn(s)
Patient Problem/Medical Problem
Deposits
Patient Problem/Medical Problem
Cancer
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Cataract
Burn(s)
Infection, Bacterial
Patient Problem/Medical Problem
Ventricle, Abnormality Of
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Edema
Pain
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Edema
C54027
Discrete, small lesions presen C54027
C34483
Complications of intraocular le C54027
Area of epithelial tissue loss C54027
A sustained, sudden and involuC54027
The patient becomes contamina
C54027
C3671
A split located on a leaflet of C54027
A bluish or purplish discolor C54027
Inflammation of the ciliary bod C54027
A morphologic finding indicatinC54027
C54027
A genus of the family herpesvirC54027
An inherited or acquired conditC35731
The cessation of life.
C54027
Death of a fetus after 10 week C54027
Shedding of accumulated boneC54027
C50416
C25637
A splitting open of an anatomicC54027
A condition resulting from the C54027
Loss of intellectual abilities
C54027
A severe, often fatal encephal C26920
Accumulation of extraneous inor
C54027
A melancholy feeling of sadne C54027
C2889
An eye emergency condition whi
C54027
with the inability to retrieve device and/or C54027
The metabolic condition resulteC54027
Pertaining to, characterized b C54027
Watery bowel movements.
C54027
Pain or discomfort with mastic C54027
Any physical or mental impairmen
C54027
C54027
The leakage of a substance from
C54027
A feeling of mental or physical C54027
C54027
C54027
A pathological process where tC2902
The condition of being stretc C54027
A state of physiological or ps C54027
A sensation of lightheadednessC54027
A syndrome characterized by drC54027
Abnormality or impairment of C54027
A symptom referring to difficul C54027
Impairment of verbal communica
C54027
An uncomfortable sensation of C54027
d
Difficulty or pain in urination. C54027
C26791
Accumulation of an excessive am
C3399
Accumulation of intraretinal fl C54027
Corneal edema of inflammatoryC50508
o
2688
2688
2061
2688
2688
2688
2688
2348
2688
2688
2688
2688
2688
2688
1882
2688
2688
2688
1718
2414
2688
2688
2688
1833
2688
2688
1732
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
1779
2688
2688
2688
2688
2688
2688
2688
2688
2688
1888
2091
2688
1791
1791
2688
2688
2688
2688
2688
2688
2688
2688
2237
2688
2688
2688
2688
2688
2681
2688
2074
2688
2688
2688
2597
2688
1849
2688
2688
2688
2418
2688
2688
2688
2688
2688
2688
2688
2688
2688
1757
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
1870
1870
1870
1870
1870
Corneal Edema
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Chronic Obstructive Pulmonary Disease, (COPD)
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Tissue Breakdown
Patient Problem/Medical Problem
Skin Discoloration
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Blood Loss
Patient Problem/Medical Problem
Fatigue
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Loss Of Consciousness
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Burn(s)
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Fracture(s)
Fracture(s)
Fracture(s)
Fracture(s)
Fracture(s)
2688
2688
2688
2688
2688
2135
2688
2137
2688
2688
2688
2688
2688
2688
2688
1994
2688
2688
2688
2688
2688
2688
2688
2688
1891
1888
1889
1888
1888
1888
2688
2688
2688
2688
2248
2688
2688
1868
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2352
2352
2688
2688
2688
2688
2688
2688
2688
1918
2688
2688
2688
2688
2688
2688
2688
2688
2414
2688
2688
1930
1930
1930
1930
1930
1930
1930
1930
1930
1930
2688
2688
2688
2688
1888
2688
1888
2688
2688
1994
2688
2688
2688
2688
2688
2688
2688
2373
2688
2373
2688
1944
2688
Hypoesthesia
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Hypoxia
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Reaction
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Infection
Infection
Infection
Infection
Infection
Infection
Infection
Infection
Infection
Infection
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Hemorrhage
Patient Problem/Medical Problem
Hemorrhage
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Pain
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Joint Disorder
Patient Problem/Medical Problem
Joint Disorder
Patient Problem/Medical Problem
Keratitis
Patient Problem/Medical Problem
C3671
C34441
C35016
Impairment of the left ventricle C54027
Failure of adequate output by C50577
Enlargement or overgrowth of tC54027
Characterized by a lack of vitalC54027
C3671
C50603
Bruising of the liver.
C50441
A finding that indicates abnorma
C54027
C54027
A level of awareness that can bC54027
C54027
C54027
Abnormal permanent enlargement
C54027
An autoimmune, connective tiss
C2889
A malignant (clonal) prolifer C9305
A feeling of general discomfort C54027
A radiologic finding indicatin C54027
the mediastinum changes to the right or l C54027
Systematic and extensive loss C54027
A disorder characterized by ac C54027
Deviations from the normal proc
C54027
Very small, round vesicles con C54027
A sudden compelling urge to urC54027
Fetal loss at less than 20 weekC35221
C54027
A dose of medicine that was noC54027
A specific reason explaining w C62596
Dysfunction of the mitral valve C50796
C54027
The backward flow of blood from
C50888
Narrowing of the left atrioventriC62433
A fairly common and often benig
C36173
Complete impairment of two o C54027
A sudden, violent, involuntary C54027
C54027
A reduction in the strength of C54027
An involuntary, persistent sta C54027
An involuntary, compulsive, re C54027
Painful sensation originating C3303
A bruise to the heart.
C50441
Gross necrosis of the myocardiu
C54027
Inflammation of the muscle tissC54027
C3284
Upper abdominal discomfort asC54027
A cell death process that is m C54027
C54027
A penetrating stab wound fromC54027
a
A congenital anatomic abnormal
C2849
An abnormality that affects hear
C2849
Partial or complete loss of the C2849
2348
1757
2072
2688
2206
2688
2688
2348
1924
1787
2688
2688
2688
2688
2688
2688
1732
3262
2688
2688
2688
2688
2688
2688
2688
2688
1688
2688
2688
Injury
Burn(s)
Shock
Patient Problem/Medical Problem
Heart Failure
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Implant, Failure Of
Contusion
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Autoimmune Disease
Cancer
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Abortion
Patient Problem/Medical Problem
Patient Problem/Medical Problem
1926
2688
1963
2697
2475
2688
2688
2688
2688
2688
2688
1994
1787
2688
2688
2422
2688
2688
2688
2688
1782
1782
1782
Insufficiency, Valvular
Patient Problem/Medical Problem
Mitral Insufficiency
Valvular Stenosis
Prolapse
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Pain
Contusion
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Obstruction
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Congenital Defect/Deformity
Congenital Defect/Deformity
Congenital Defect/Deformity
2688
2688
2688
2688
2348
2688
2688
2688
2688
3192
2688
3192
3192
2688
2688
3192
2688
2688
2422
1979
1845
2001
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
1994
1994
2688
2688
2688
2688
2688
1997
2695
2688
2688
2688
2688
2348
2688
2219
2688
2688
2688
2688
2688
2688
2688
2688
2348
2688
2688
2688
2688
1750
2688
2688
2688
2688
2688
2274
2688
2688
2688
2688
2688
2688
2688
2688
1829
2688
2688
2688
2697
2688
2688
2688
2686
2688
2688
1757
2688
1988
2688
2542
2443
2688
2688
2688
2688
2414
2414
2688
2688
1926
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
1845
2688
2048
2688
2688
2054
2688
2348
2688
2688
3167
1732
1757
2688
2688
2063
2063
2260
2063
2688
2688
2688
2688
2348
2072
2072
2072
2072
2072
2267
2072
2072
2072
2001
1732
2688
1750
2688
1941
2688
2688
2688
2688
2689
2348
2348
2688
2688
2688
2688
2688
2688
2348
1802
2688
2688
1689
2688
2688
2688
2688
2688
2688
2688
2688
2688
2219
2688
2688
2688
2688
2688
1757
1829
2688
2688
2688
2688
2688
2104
2348
2132
1735
2688
2348
2688
2688
2688
2688
1926
2111
2697
2688
2688
2688
2348
2688
Injury
Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Death
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Abrasion
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Brain Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Burn(s)
Embolism
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Tissue Damage
Injury
Ventricular Tachycardia
Infection, Bacterial
Patient Problem/Medical Problem
Injury
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Insufficiency, Valvular
Tricuspid Insufficiency
Valvular Stenosis
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Patient Problem/Medical Problem
Injury
Patient Problem/Medical Problem
C54027
C54027
Urination at short intervals; it C54027
Accumulation of urine within thC54027
A transient, itchy skin eruptio C2983
A rupture in the uterus due to C4080
An inflammatory process affectiC54027
Normal or abnormal secretionsC54027
C3671
Narrowing of the opening of one
C50754
C54027
Vasoconstriction involves narr C54027
Vasodilation involves widening C54027
Sudden drop of the blood pressu
C54027
A disorder acquired through seC26726
Technique used to draw blood fC54027
C54027
C54027
A disorder characterized by an C54027
A disorder characterized by anC50802
A disorder characterized by a C54027
A feeling of movement, a sensat
C54027
ments of device are embedded in patient's C34620
Damage to a blood vessel resulti
C54027
An infectious agent which consiC54027
C54027
C54027
C54027
Surgical removal of the vitreo C54027
Spots before the eyes caused b
C54027
Blood extravasation in the vit C54027
C54027
C54027
Inflammatory intraocular reactioC54027
Forceful ejection of the conte C54027
The property of lacking physicaC54027
C54027
A smooth, slightly elevated areC50624
Splitting of the sutured margin C50527
Wound Infection
C54027
Wound Infection
C54027
C54027
C50527
2688
2688
2688
2688
2443
2001
2688
2688
2348
2263
2688
2688
2688
2688
1930
2688
2688
2688
2688
2132
2688
2688
2687
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
2688
1941
2502
2688
2688
2688
2502
FDA Source PT
edical Problem
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
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t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
Or Reagent
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
peutic, Or Research Equipment
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
able Read Only Memory)
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
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t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
t Or Accessory
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t Or Accessory
t Or Accessory
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t Or Accessory
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t Or Accessory
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g Evaluation
mistry Evaluation
mistry Evaluation
mistry Evaluation
g Evaluation
mistry Evaluation
mistry Evaluation
cess Problem
cess Problem
ompatibility Problem
mistry Problem
ompatibility Problem
Foreign Material
mistry Problem
ompatibility Problem
mistry Problem
cess Problem
cess Problem
Foreign Material
Foreign Material
cess Problem
cess Problem
ompatibility Problem
mistry Problem
cess Problem
cess Problem
cessory Incompatibility
Or Reagent Issue
nation Of Device
ntrol Or Utility Issue
Device Component
cessory Incompatibility
Shipping Issue Associated With Device
erface Issue
quate Result
Programming Calculations
ompatibility Issue
ompatibility Issue
e Or Device Component
e Or Device Component
Or Properly Shock
Or Properly Shock
n Or Sterilization Issue
r Transmission Issue
Properly Pace
n Or Sterilization Issue
r Transmission Issue
quate Result
quate Result
quate Result
n Device Environment
n Device Environment
mental Factor
Or Reagent Issue
quate Result
Properly Pace
erface Issue
Or Properly Shock
Compromised
Shipping Issue Associated With Device
quate Result
quate Result
Or Properly Shock
quate Result
dity Problem
ntrol Or Utility Issue
Properly Pace
ng System Issue
ng System Issue
Properly Pace
Properly Pace
Properly Pace
Properly Pace
Shipping Issue Associated With Device
Programming Calculations
ate Or Deposit In Device Or Device Ingredient
Programming Calculations
or Activation
or Activation
r Transmission Issue
ompatibility Issue
Or Reagent Issue
Prior To Use
Compromised
r Transmission Issue
Security Issue
quate Result
Compromised
r Transmission Issue
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
eased Or Low
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
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edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
e Pulmonary Disease, (COPD)
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
edical Problem
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