Urgent Field Safety Notice Puritan Bennett™ 840 Ventilator - Operator's Manual Update For Loss of GUI Display

URGENT FIELD SAFETY NOTICE
Puritan Bennett™ 840 Ventilator – Operator’s Manual Update for Loss of GUI
Display

DAY MONTH, 2014

Reference: PB840 – Loss of Display, Manual Update 08/14
Dear Valued Customer,

Covidien is issuing this field safety notice (FSN) to its Puritan Bennett™ 840 ventilator customers to
provide new information for the Puritan Bennett™ 840 Ventilator Operator’s Manual. Accompanying this
notice is a new insert for Table 1-2 in Chapter 1 and an entire new Chapter 13. These new pages provide
additional instruction and information for interacting with loss of display events. You are receiving this
communication because our records indicate you may have one or more of the Puritan Bennett 840
Ventilator Operator’s Manuals affected by this notice.
The customer reports that initiated these changes to the Operator’s Manual included the graphical user
interface (GUI) display screens (both upper and lower) becoming blank or erratic during patient use.
This event prevents the clinician viewing and/or changing ventilator settings or clinician-set patient
alarm parameters. Loss of display on GUI display screens will result in a patient requiring prompt
transfer to an alternate ventilator in a manner consistent with relevant protocols. The ventilator
continues to provide respiratory support during these events.
If this condition does not occur, the Puritan Bennett 840 ventilator can continue to be used.
Loss of GUI display

Failure of various components may result in screens going blank or becoming erratic. However,
mechanical ventilation continues as set. All ventilator alarms remain active and will activate if alarm limits
are exceeded.
If you encounter a loss of display, please take the following actions in conjunction with your
institutional protocols to minimize risk to the patient.
• Verify the patient’s respiratory and physiological stability.

o Confirm the patient is receiving ventilatory support by observation of the
expansion and contraction of the patient’s chest.
o Assess current patient status by reviewing other monitoring (e.g., oxygen
saturation, heart rate, blood pressure, etc.)
• Promptly transfer the patient to an alternate ventilator in a manner consistent with
your institutional protocol.
• Remove the affected ventilator from use until it has been serviced.
Page 1 of 2
URGENT FIELD SAFETY NOTICE
Puritan Bennett™ 840 Ventilator – Operator’s Manual Update for Loss of GUI
Display

Actions to be taken
• Remove Table 1-2 from Chapter 1 and destroy; replace with the enclosed replacement page.
Please note the “Display (GUI) INOP” indicator image and the reference to Table 13-3 for
recommended actions.
• Remove the entire Chapter 13 from your existing manual and destroy.
• Replace with the enclosed new section provided. Please review the details in Table 13-3 for
information related to loss of GUI display.
• Communicate this new updated information within your facility as needed.
• Complete the attached acknowledgment form and fax or email it to the Covidien contact
indicated on the form.
Important Safety Reminders
Always follow the instructions described in the Puritan Bennett™ 840 Ventilator Operator’s and
Technical Reference Manual.
• Patients on life-support equipment should be appropriately monitored by medical personnel

and suitable monitoring devices. (Preface)
• An alternative source of ventilation should always be available when using a critical care
ventilator. (Preface)
o When using the ventilator’s selectable alarm volume range, be sure to select an
alarm volume level that can be discerned above background noise levels.
(Section 5.5)
o To ensure proper ventilator operation, perform the maintenance procedures at the
recommended intervals as summarized in Table 7-3 in the Puritan Bennett™ 840
Operator’s and Technical Reference Manual.
This notification is being issued with the knowledge of [add local Competent Authority]. Please
communicate this important information within your facility as required. If your facility has distributed
Puritan Bennett™ 840 ventilators to other persons or facilities, please promptly forward a copy of this
letter to those recipients.
If you have any questions regarding this letter, please contact your local Covidien representative
COUNTRY SPECIFIC TELEPHONE NUMBER. Thank you for your prompt attention to this matter.
Sincerely,
Country Specific
Regulatory Affairs
Enclosed
Page 2 of 2
The indicators on the breath delivery unit are shown in Table 1-2.
Table 0-1:
1-2 BDU indicators
Red ventilator inoperative indicator: The ventilator cannot support
ventilation and requires service. The ventilator enters the safe state
(safety ventilation) and discontinues detection of new patient data
or alarm conditions. Qualified service personnel must repair the
ventilator to correct the problem and execute EST successfully
before normal ventilation is allowed. This indicator is accompanied
by an audio signal and cannot be reset.
Red safety valve open (SVO) indicator: The ventilator has entered
its safe state and opened its safety valve to allow the patient to
breathe unassisted from room air.
Red loss of GUI indicator: The ventilator has detected a

malfunction that prevents the GUI from reliably displaying or
receiving information. If you encounter a loss of the GUI display,
reference Table 13-3 on page TR 13-21 for a list of recommended
actions.
Puritan Bennett™ 800 Series Ventilator System Operator’s Manual 10132669A00

Alarms 13
This chapter discusses the ventilator’s alarm handling

strategy and provides supplementary information about
selected ventilator alarms for the Puritan Bennett™ 840
Ventilator System. For settings ranges, resolutions, and
new patient values of all alarms, see Table A-13 in
Appendix A of this manual.
Current alarm settings are saved in nonvolatile memory.
All ventilator settings have absolute limits, which are
intended to prevent settings outside the safe or
permissible operational range of the ventilator. These
limits may be fixed or depend on other settings, such as
ideal body weight (IBW).
13.1 Alarm handling

The Puritan Bennett™ 840 Ventilator System’s alarm
handling strategy is to:
• Detect and call attention to legitimate causes for
caregiver concern as quickly as possible, while
minimizing nuisance alarms.
• Identify the cause and suggest corrective action for
an alarm where possible.
• Make it easy to discern an alarm’s urgency level.
• Allow quick and easy alarm setup.
10132669A00
Alarms
Alarm annunciations include a level of urgency, which is an estimate

of how quickly a caregiver must respond to ensure patient
protection. Table 13-1 summarizes alarm urgency levels.
Table 13-1: Alarm urgency levels
Urgency Visual Audible

Autoreset handling
level indication indication
High: Red High-priority If all high-urgency alarm

Hazardous flashing tone conditions return to normal,
situation (repeating the audible indicator turns
requiring sequence of off, the red high-urgency
immediate five tones; indicator switches from
response sequence flashing to steadily lit, and
repeats twice, autoreset is entered in the
pauses, then alarm history log. Press the
repeats again) alarm reset key to turn off
the visual indicator.
Medium: Yellow Medium- If all medium-urgency alarm

Abnormal flashing priority tone conditions return to normal,
situation (repeating the audible and visual
requiring sequence of indicators turn off and
prompt three tones) autoreset is entered into the
response alarm history log.
Low: Yellow, Low-priority If all low-urgency alarm

Change in steadily lit tone (two conditions return to normal,
status, tone, non- the audible and visual
informing repeating) indicators turn off and
clinician autoreset is entered in the
alarm history log.
Normal: Green, None Not applicable.

No alarm steadily lit
conditions
active (may
include
autoreset
alarms)
TR 13-2 Puritan Bennett™ 800 Series Ventilator System Technical Reference 10132669A00
Alarms
13.1.1 Alarm messages

In addition to displaying the urgency level of an alarm, the ventilator
displays alarm messages for the two highest-priority active alarms
near the top of the graphic user interface (GUI) upper screen.
Figure 13-1 shows the format for alarm messages.
The base message identifies

the alarm. Touch alarm The analysis message gives the root
symbol to view definition cause of the alarm. May also include
on lower screen. dependent alarms.
The two highest-
} priority active
alarm messages
are displayed here.
The remedy
message suggests
how to resolve
the alarm condition.
Touch flashing MORE ALARMS

button to view messages for up to
six additional active alarms.
Figure 13-1. Alarm message format (upper GUI screen)
The following rules define how alarm messages are displayed:

• If the ventilator is interfaced to an external device to collect data
for trending and other monitoring purposes, that external data is
not considered in alarm handling.
• Initial alarms, called primary alarms precede any dependent
alarms, those alarms arising from primary alarms.
• The system adds dependent alarms to the analysis messages of
each active primary alarm with which they are associated. If a
dependent alarm resets, the system removes it from the analysis
message of the primary alarm.
10132669A00 Puritan Bennett™ 800 Series Ventilator System Technical Reference TR 13-3
Alarms
• The urgency level of a primary alarm is equal to or greater than

the urgency level of any of its active dependent alarms.
• An alarm cannot be a dependent alarm of any alarm that occurs
subsequently.
• If a primary alarm resets, any active dependent alarms become
primary unless they are also dependent alarms of another active
primary alarm.
• The system applies the new alarm limit to alarm calculations from
the moment of change to an alarm limit.
• The urgency level of a dependent alarm is based solely on its
detection conditions (not the urgency of any associated alarms).
• When an alarm causes the ventilator to go to idle mode,
occlusion status cycling (OSC), or safety valve open (SVO), the
patient data display (including waveforms) is blanked. The
elapsed time without ventilatory support (that is, since idle
mode, OSC, or SVO began) is displayed on the upper GUI screen.
If the alarm causing idle mode, OSC, or SVO is autoreset, the
ventilator resets all patient data alarm detection algorithms.
13.1.2 Alarm summary

Table 13-2 summarizes ventilator alarms, including urgency,
messages, and other information.
Table 13-2: Alarm summary
Analysis Remedy
Base message Urgency Comments
message message
AC POWER Low Operating on Prepare Power switch on, AC

LOSS battery. for power power not available,
loss. ventilator operating
Medium Operational on BPS. BPS
time operating indicator
< 2 minutes. turns on. Resets
when AC power is
restored.
Alarms
Analysis Remedy
message message
APNEA Medium Apnea Check The set apnea

(patient data ventilation. patient & interval has elapsed
alarm) Breath settings. without the
interval ventilator, patient,
> apnea or operator
interval. triggering a breath.
Resets when patient
High Extended initiates 2
apnea consecutive breaths.
duration or Possible dependent
multiple alarm: VE TOT.
apnea events.
CIRCUIT High No Check Ventilator has

DISCONNECT ventilation. patient/ recovered from
ventilator unintended power
status. loss lasting more
than 5 minutes,
detects circuit
disconnect, and
switches to idle
mode; upper screen
displays elapsed
time without
ventilator support.
Resets when
ventilator senses
reconnection.
High No Check Ventilator detects

ventilation. patient. circuit disconnect
Reconnect and switches to idle
circuit. mode; upper screen
displays elapsed
time without
ventilator support.
Resets when
ventilator senses
reconnection.
Alarms
Analysis Remedy
message message
COMPLIANCE Low Compliance Inspired Compliance volume

LIMITED VT compensation volume required to
(patient data limit reached. may be compensate delivery
alarm) < set. of a volume
Check controlled breath
patient exceeds the
and circuit maximum allowed
type. for 3 of the last
4 breaths.
COMPRESSOR Low No No Compressor ready

INOPERATIVE compressor remedy indicator turns off.
air. No message Resets when full AC
operation displayed power is restored.
during low
AC power.
Low No Ventilator turns off

compressor compressor. Resets
air. No when full AC power
operation is restored.
during A/C
power loss.
Low No Compressor ready

compressor indicator turns off.
air.
Low N/A Replace Alarm occurs when

compressor. there are no LOW
AC POWER and no
AC POWER LOSS
alarms for
< 15 seconds AND
time since power-on
> 10 seconds.
Alarms
Analysis Remedy
message message
DEVICE Low Breath Service Background checks

ALERT delivery not required. have detected a
affected. problem. Resets
when ventilator
Low Ventilation Replace & passes EST.
continues as service
set. ventilator.
Low Breath
delivery not
affected.
Compromised
spirometry.
Low Breath Service POST has detected a

delivery not required. problem. Resets
affected. when ventilator
Possible passes POST.
compromise
of other
functions.
Medium Ventilation Replace & Background checks

continues as service have detected a
set. ventilator. problem. Accuracy
of exhalation flow
sensor temperature
may be affected.
Resets when
ventilator passes EST.
Alarms
Analysis Remedy
message message
DEVICE Medium Ventilation Replace & Background checks

ALERT (cont) continues as service have detected a
of oxygen flow
sensor temperature
may be affected,
ventilator using
nominal value.
Resets when
Medium Breath Background checks

delivery not have detected a
affected. problem persisting
Compromised for over 10 minutes.
spirometry. Resets when
Medium Ventilation Background checks

continues as have detected a
set. Only O2 problem. Ventilator
available. delivers 100% O2.
Resets when
Medium Breath Check Background checks

delivery not patient. have detected a
affected. Replace & problem. Accuracy
Compromised service of exhalation flow
spirometry. ventilator. sensor temperature
may be affected.
Resets when
Alarms
Analysis Remedy
message message
DEVICE Medium Ventilation Replace & Background checks

set. Only air ventilator. problem. Ventilator
available. delivers 21% O2.
Resets when
High Breath Background checks

delivery not have detected a
affected. problem. Loss of GUI
indicator lights.
Setting changes
disabled. Resets
when ventilator
passes EST.
Reference Table 13-3
on page TR 13-21 for
information on
actions to take.
High Unable to Check Background checks

determine patient. have detected a
status of Replace & problem. Loss of GUI
breath service indicator lights.
delivery. ventilator. Resets when
communication
between GUI and
BDU is re-
established.
High Ventilation Replace & Background checks

set. ventilator. problem. Loss of GUI
indicator lights.
Alarms, setting
changes, and
monitored data
disabled. Resets
when ventilator
passes EST.
Reference Table 13-3
on page TR 13-21 for
information on
actions to take.
Alarms
Analysis Remedy
message message
DEVICE High Ventilation Replace & Background checks

set. ventilator. problem. Setting
changes, monitored
data, and alarms
disabled. Resets
when ventilator
passes EST.

set. Delivery/ ventilator. problem. Setting
spiro may be changes not
compromised. allowed. Resets
when ventilator
passes EST.
High Breath Check Background checks

delivery not patient. have detected a
affected. Replace & problem and flow
Compromised service triggering was
spiro. ventilator. selected. Accuracy of
Trig = pres. exhalation flow
sensor temperature
may be affected.
Resets when
High Ventilation Check Background checks

continues as patient. have detected a
set, except Replace & problem. Ventilator
O2% = 100 service delivers 100% O2
ventilator. instead of set O2%.
Resets when
Alarms
Analysis Remedy
message message
DEVICE High Ventilation Replace & Background checks

Compromised Check of air flow sensor
air delivery patient. temperature may be
affected, ventilator
using nominal value.
Resets when

Compromised Check of oxygen flow
O2 delivery patient. sensor temperature
may be affected,
ventilator using
nominal value.
Resets when
High Power loss & Check Background checks

recovery Alarm log. have detected a
occurred with EST problem. Loss of GUI
a pre-existing required. indicator lights.
Device Alert. Resets when
High Ventilation Check Background checks

continues as patient. have detected a
set, except Replace & problem. Ventilator
O2% = 21. service delivers 21% O2
ventilator. instead of set O2%.
Resets when
Alarms
Analysis Remedy
message message
DEVICE High No Provide Background checks

ALERT (cont) ventilation. alternate have detected a
Safety Valve ventilation.problem. Safety
Open. Replace & valve open indicator
service lights. Upper screen
ventilator. displays elapsed
time without
High No Check ventilator support.
ventilation. patient. Resets when
Safety Valve Replace & ventilator passes EST.
Open. service
ventilator.
High No Provide Background checks

ventilation. alternate have detected a
Safety Valve ventilation. problem. Ventilator
Open. Replace & inoperative and
service safety valve open
ventilator. indicators light.
Message may not be
visible. If possible,
upper screen
displays elapsed
time without
ventilator support.
Resets when
PPEAK Low Last breathCheck Measured airway

(patient data  set limit.
patient, pressure  set limit.
alarm) circuit & Ventilator truncates
Medium Last 3 breaths ET tube. current breath
 set limit. unless already in
exhalation. Possible
High Last 4 or dependent alarms:
more breaths V TE MAND , VE TOT,
 set limit.  fTOT .
Alarms
Analysis Remedy
message message
3PPEAK Low Last 2 Check for Peak inspiratory

(patient data breaths, leaks. pressure set limit.
alarm) pressure  set (Available only when
limit. Vent Type is NIV or
during INVASIVE
Medium Last 4 ventilation when
breaths, Mandatory Type is
pressure  set VC+.)
limit.
High Last 10 or
more breaths,
pressure  set
limit.
O2% Medium Measured Check The O2% measured

(patient data O2% > set for patient, during any phase of
alarm)  30s but gas a breath cycle is 7%
< 2 min. sources, (12% during the first
O2 hour of operation)
High Measured analyzer & or more above the
O2% > set ventilator. O2% setting for at
for 2 min. least 30 seconds.
(These percentages
increase by 5% for
4 minutes following
a decrease in the
O2% setting.) Alarm
updated at 1-second
intervals.
 VTE Low Last 2 breaths Check Exhaled tidal volume

(patient data  set limit. settings,  set limit. Alarm
alarm) changes in updated whenever
Medium Last 4 breaths patient’s exhaled tidal volume
 set limit. R & C. is recalculated.
Possible dependent
High Last 10 or alarm: 1VE TOT.
more breaths
 set limit.
Alarms
Analysis Remedy
message message
 VE TOT Low V E TOT  set Check Expiratory minute

(patient data limit for patient & volume  set limit.
alarm)  30s. settings. Alarm updated
whenever an
Medium V E TO set exhaled minute
limit for volume is
> 30s. recalculated.
Possible dependent
High VE TOT  set alarm:  VTE.
limit for
> 120s.
fTOT (patient Low fTOT  set Check Total respiratory rate

data alarm) limit for patient &  set limit. Alarm
 30s. settings. updated at the
beginning of each
Medium fTOT  set inspiration. Reset
limit for when measured
> 30s. respiratory rate falls
below the alarm
High fTOT  set limit. Possible
limit for dependent alarms:
> 120s. VTE MAND ,
VTE SPONT , VE TOT.
PVENT Low 1 breath Check Inspiratory pressure

(patient data  limit. patient, > 100 cmH2O and
alarm) circuit & mandatory type =
Medium 2 breaths ET tube. VC or spontaneous
 limit. type= TC or PA.
Ventilator truncates
High 3 or more current breath
breaths unless already in
 limit. exhalation. Possible
dependent alarms:
VTE MAND,
VE TOT , fTOT.
Alarms
Analysis Remedy
message message
INOPERATIVE Low Inadequate Service/ BPS installed but not

BATTERY charge or replace functioning. Resets
non- battery. when BPS is
functional functional.
battery
system.
INSPIRATION Low Last 2 spont Check Inspiratory time for

TOO LONG breaths = IBW patient. spontaneous breath
(patient data based TI limit. Check for  IBW-based limit.
alarm) leaks. Ventilator
Medium Last 4 spont transitions to
breaths = IBW exhalation. Resets
based TI limit. when TI falls below
IBW-based limit.
High Last 10 or Active only when
more spont Vent Type is
breaths = IBW INVASIVE.
based TI limit.
LOSS OF High The ventilator

POWER power switch is on
and there is
insufficient power
from AC and the BPS
(if installed). There
may not be a visual
indicator for this
alarm, but an
independent audio
alarm sounds for at
least 120 seconds.
Alarm annunciation
can be reset by
turning power
switch to off
position.
Alarms
Analysis Remedy
message message
LOW AC Low Ventilator Power Mains (AC) power

POWER currently not interrupt has dropped below
affected. possible. 80% of nominal for
1 second. Ventilator
continues operation
as close to settings as
possible. Resets
when there is no low
AC power signal for
1 second.
LOW Low Operational Replace or Resets when BPS has

BATTERY time < 2 allow more than
minutes. recharge. approximately
2 minutes of
operational time
remaining.
O2% High Measured Check The O2% measured

(patient data O2% < set patient, during any phase of
alarm) O2%. gas a breath cycle is 7%
sources, (12% during the first
O2 hour of operation)
analyzer & or more below the
ventilator. O2% setting for at
least 30 second, or
below 18%. (These
percentages increase
by 5% for 4 minutes
following an
increase in the O2%
setting.) Alarm
updated at 1-second
intervals.
Alarms
Analysis Remedy
message message
VTE MAND Low Last 2 mand. Check for Exhaled mandatory

(patient data breaths  set leaks, tidal volume  set
alarm) limit. changes in limit. Alarm updated
patient‘s whenever exhaled
Medium Last 4 mand. R & C. mandatory tidal
breaths  set volume is
limit. recalculated.
Possible dependent
High Last 10 or alarms:
more mand.  VE TOT , fTOT .
breaths  set
limit.
VTE SPONT Low Last 2 spont Check Exhaled

(patient data breaths  set patient & spontaneous tidal
alarm) limit. settings. volume  set limit.
Alarm updated
Medium Last 4 spont whenever exhaled
breaths  set spontaneous tidal
limit. volume is
recalculated.
High Last 10 or Possible dependent
more spont alarms:
breaths  set 3VE TOT, f TOT.
limit.
VE TOT Low V E TO set Check Total minute volume

(patient data limit for patient &  set limit. Alarm
alarm)  30s. settings. updated whenever
exhaled minute
Medium V E TO set volume is
limit for recalculated.
> 30s. Possible dependent
alarms:
High V E TO set VTE MAND,
limit for VTE SPONT , fTOT.
> 120s.
Alarms
Analysis Remedy
message message
NO AIR Low Ventilation Check air Operator-set O2%

SUPPLY continues as source. equals 100%.
set. Only O2 Ventilator delivers
available. 100% O2. Resets if
air supply
Low Compressor connected.
inoperative.
Ventilation
continues as
set. Only O2
available.
High Ventilation Check Operator-set O2%

continues as patient & < 100%. Ventilator
set except air source. delivers 100% O2
O2% = 100 instead of set O2%.
Resets if air supply
High Compressor connected.
inoperative.
Ventilation
continues as
set, except
O2% = 100.
NO AIR High No Provide Safety valve open

SUPPLY ventilation. alternate indicator lights.
and NO O2 Safety Valve ventilation. Upper screen
SUPPLY Open. Check displays elapsed
both gas time without
sources. ventilator support.
Safety valve closes
and indicator turns
off if either gas
supply is connected.
Individual gas supply
alarm resets when
corresponding
supply is connected.
Alarms
Analysis Remedy
message message
NO O2 Low Ventilation Check O2 Operator-set O2%

SUPPLY continues as source. equals 21%. Resets if
set. Only air O2 supply
available. connected.
High Ventilation Check Operator-set O2%

continues as patient & > 21%. Ventilator
set, except O2 source delivers 21% O2
O2% = 21. instead of set O2%.
Resets if oxygen
supply connected.
O2 SENSOR Low Ventilation O2 sensor Background checks

unaffected. out of have detected a
calibration problem. Resets
/failure. when operator
Press successfully
100% O2 calibrates oxygen
CAL or sensor, or disables
INCREASE oxygen sensor.
O2 2 min,
replace or
disable.
PROCEDURE High Patient Provide Ventilator begins

ERROR connected alternate safety ventilation.
before setup ventilation. Resets when
complete. Complete ventilator startup
setup procedure is
process. complete.
Alarms
Analysis Remedy
message message
SCREEN Medium Possible Remove Background checks

BLOCK blocked beam obstruction have detected a
or touch or service problem. Resets
screen fault. ventilator. when ventilator
passes EST or when
blockage is removed.
SEVERE High Little/no Check Ventilator enters

OCCLUSION ventilation. patient. occlusion status
Provide cycling (OSC) and
alternate upper screen
ventilation. displays elapsed
Clear time without
occlusions; ventilator support.
drain
circuit.
Alarms
Table 13-3: Loss of GUI Display
Recommended
Symptom Alarm Condition Ventilator Function
Action
Loss of GUI display • Loss of GUI • Ventilation • Verify the

(upper and lower) indicator continues as set patient’s
• Breath delivery respiratory and
not affected physiological
stability.
• Audible alarms
• Confirm the
not affected.
patient is
receiving
ventilator support
by observation of
the expansion
and contraction
• High priority of the patient’s
audible alarm chest.
• Assess current
patient status by
review of other
monitoring
indicators (e.g.
oxygen
saturation, heart
rate, blood
pressure, etc.).
• Promptly transfer
the patient to an
alternate source
of ventilation
consistent with
your institutional
protocol.
• Remove the
affected
ventilator from
use until it has
been serviced.
Alarms
Table 13-3: Loss of GUI Display (cont)

Loss of display No alarm messages • Ventilation • Verify the
(upper, lower, or displayed continues as set patient’s
both) and … respiratory and
• Breath delivery
not affected physiological
stability.
• Audible alarms
• Confirm the
not affected
patient is
• Alarm status receiving
indicator panel ventilator support
functions by observation of
the expansion
and contraction
of the patient’s
chest.
• Assess current
patient status by
review of other
monitoring
indicators (e.g.
oxygen
saturation, heart
rate, blood
pressure, etc.).
• Promptly transfer
the patient to an
alternate source
of ventilation
consistent with
your institutional
protocol.
• Remove the
affected
ventilator from
use until it has
been serviced.
Alarms
Table 13-3: Loss of GUI Display (cont)

Loss of GUI display • VENT INOP Ventilator is not Immediately
(upper, lower, or displayed on providing breaths, transfer the patient
both) and … BDU ventilator to an alternate
assistance, or source of
supplemental ventilation
oxygen.
13.2 AC POWER LOSS alarm

The AC POWER LOSS alarm indicates the ventilator power switch is
on and the ventilator is being powered by the backup power source
(BPS). The ventilator annunciates a low-urgency alarm when the
ventilator has been operated by the BPS for at least 3 seconds and at
least 2 minutes of BPS power are available. The ventilator
annunciates a medium-urgency alarm when less than 2 minutes of
BPS power are estimated available.
The AC POWER LOSS alarm indicates the ventilator is being powered
by the BPS and an alternate power source may soon be required to
sustain normal ventilator operation. During an AC POWER LOSS
condition, power to the humidifier and compressor is not available.
13.3 APNEA alarm

The APNEA alarm indicates neither the ventilator nor the patient has
triggered a breath for the operator-selected apnea interval (TA). TA is
measured from the start of an inspiration to the start of the next
inspiration and is based on the ventilator’s inspiratory detection
criteria. TA can only be selected via the apnea ventilation settings.
The APNEA alarm autoresets when the patient initiates two
successive breaths, and is intended to establish the patient's
inspiratory drive is reliable enough to resume normal ventilation. To
ensure the breaths are patient-initiated (and not due to
autotriggering), exhaled volumes must be at least half the VT (this
avoids returning to normal ventilation if there is a disconnect).
Alarms
The ventilator monitors breathing from the start of inspiration to

the start of inspiration and allows the ventilator to declare apnea
when the patient fails to take a breath, rather than when he/she fails
to exhale on schedule.
13.4 CIRCUIT DISCONNECT alarm

The CIRCUIT DISCONNECT alarm indicates the patient circuit is
disconnected at the ventilator or the patient side of the patient wye,
or a large leak is present. The methods by which circuit disconnects
are detected vary depending on breath type. Time, pressure, flow,
delivered volume, exhaled volume, and the DSENS setting may be
used in the circuit disconnect detection algorithms. See Section 10.2
on page TR 10-3 for a complete discussion of the CIRCUIT
DISCONNECT detection methods.
You can set the sensitivity of the CIRCUIT DISCONNECT alarm by
adjusting the DSENS setting. During a CIRCUIT DISCONNECT
condition, the ventilator enters idle mode and delivers a 10 L/min
flow of oxygen to detect a reconnection.
When the ventilator determines the patient circuit is reconnected,
the CIRCUIT DISCONNECT alarm autoresets and normal ventilation
resumes without having to manually reset the alarm (for example,
following suctioning).
A disconnected patient circuit interrupts gas delivery and patient
monitoring. Notification of a patient circuit disconnect is crucial,
particularly when the patient cannot breathe spontaneously. The
ventilator does not enter apnea ventilation when a disconnect is
detected to avoid changing modes during a routine suctioning
procedure.
13.5 DEVICE ALERT alarm

A DEVICE ALERT alarm indicates a background test or power on self
test (POST) has failed. Depending on which test failed, the ventilator
either declares an alarm and continues to ventilate according to
current settings, or ventilates with modified settings, or enters the
ventilator inoperative state. The DEVICE ALERT alarm relies on the
ventilator’s self-testing and notifies you of an abnormal condition
requiring service.
Alarms
13.6 High circuit pressure alarm

The high circuit pressure (1P PEAK ) alarm indicates the currently
measured airway pressure is equal to or greater than the set 1P PEAK
limit. The 1P PEAK limit is active during mandatory and spontaneous
breaths, and during inspiration and exhalation. The 1P PEAK limit is
active in all normal ventilation modes. The 1P PEAK limit is not active
during a SEVERE OCCLUSION alarm.
The 1P PEAK limit cannot be set less than:
PEEP + 7 cmH2O, or
PEEP + PI + 2 cmH2O, or
PEEP + PSUPP + 2 cmH2O
nor can it be set less than or equal to 4P PEAK .
You cannot disable the 2P PEAK limit. The ventilator phases in
changes to the 2P PEAK limit immediately to allow prompt
notification of a high circuit pressure condition.
The minimum 2P PEAK limit (7 cmH2O) corresponds to the lowest
peak pressures not due to autotriggering anticipated during a
mandatory breath. The maximum 2P PEAK limit (100 cmH2O) was
selected because it is the maximum pressure required to inflate the
lungs of a patient with very low-compliance lungs.
The ventilator allows circuit pressure to rise according to a computed
triggering profile for the initial phase of PC and PS breaths without
activating the 2P PEAK alarm. This triggering profile helps avoid
nuisance alarms due to possible transient pressure overshoot in the
airway when aggressive values of rise time % are selected. A
pressure overshoot measured in the patient circuit is unlikely to be
present at the carina.
The 2P PEAK alarm is active throughout inspiration and exhalation to
provide redundant patient protection (for example, to detect
occlusions downstream of the pressure-sensing device).
13.7 High delivered O2% alarm

The high delivered O2% (O2%) alarm indicates the measured O2%
during any phase of a breath is at or above the error percentage
above the O2% setting for at least 30 seconds. Although the
ventilator automatically sets the O2% alarm limits, you can disable
Alarms
the oxygen sensor. (The error percentage is 12% above setting for
the first hour of ventilator operation, 7% above setting after the
first hour of operation, and an additional 5% above setting for the
first four minutes following a decrease in the setting.)
The ventilator automatically adjusts the O2% alarm limit when
O2% changes due to 100% O2, apnea ventilation, occlusion, circuit
disconnect, or a NO AIR/O2 SUPPLY alarm. The ventilator checks the
O2% alarm limit against the measured oxygen percentage at 1-
second intervals.
The O2% alarm detects malfunctions in ventilator gas delivery or
oxygen monitor. The O2% alarm limit automatically adjusts during
100% O2 suction, apnea ventilation, patient circuit disconnect, or
low air inlet pressure because O2% changes are expected under
those circumstances. The ventilator declares a O2% alarm after 30
seconds to eliminate transient O2% delivery variation nuisance
alarms.
13.8 High exhaled minute volume alarm

The high exhaled minute volume (VE TOT ) alarm indicates the
measured exhaled total minute volume for spontaneous and
mandatory breaths is equal to or greater than the set VE TOT limit.
The VE TOT alarm is updated whenever a new value is available.
The VE TOT alarm can be used to detect a change in a patient's
breathing pattern, or a change in compliance or resistance. The
VE TOT alarm can also detect too-large tidal volumes, which could
lead to hyperventilation and hypocarbia.
The VE TOT alarm is effective immediately upon changing the
setting, to ensure prompt notification of prolonged high tidal
volumes.
13.9 High exhaled tidal volume alarm

The high exhaled tidal volume (VTE) alarm indicates the measured
exhaled tidal volume for spontaneous and mandatory breaths is
equal to or greater than the set VTE limit. The VTE alarm is
updated whenever a new measured value is available.
The VTE alarm can detect increased exhaled tidal volume (due to
greater compliance and lower resistance) and prevent
Alarms
hyperventilation during pressure control ventilation or pressure

support. You can turn the VTE alarm OFF to avoid nuisance alarms.
(Hyperventilation due to increased compliance is not a concern
during volume-based ventilation, because the tidal volume is fixed
by the clinician's choice and the ventilator’s compliance-
compensation algorithm.)
13.10 High inspired tidal volume alarm

The high inspired tidal volume alarm indicates the patient’s inspired
volume exceeds the set limit. When this condition occurs, the breath
terminates and the alarm sounds. The selected combination of
mandatory and/or spontaneous breath type settings determines the
symbol appearing in the alarm message, alarm log, and alarm
settings screen (  VTI ,  VTI MAND , or  VTI SPONT ). The ventilator system
displays monitored inspired tidal volume values in the patient data
area on the GUI screen. Table 13-4 shows the symbol corresponding
to the ventilator settings in effect.
Table 13-4: Applicability of high inspired tidal volume alarm

symbols
Alarm setting or Mandatory or spontaneous

Alarm symbol patient data symbol type setting
VTI VTI VC+ and TC (concurrently)
VTI MAND VTI MAND VC+
VTI SPONT VTI SPONT VS or TC
When Vent Type is NIV, there is no high inspired tidal volume alarm
or setting available, but the monitored inspired tidal volume (VTI)
appears in the patient data area on the GUI screen.
13.11 High respiratory rate alarm

The high respiratory rate (fTOT) alarm indicates the measured
breath rate is greater than or equal to the set fTOT limit. The fTOT
alarm is updated whenever a new total measured respiratory rate is
available.
Alarms
The fTOT alarm can detect tachypnea, which could indicate the tidal
volume is too low or the patient's work of breathing has increased.
The ventilator phases in changes to the fTOT limit immediately to
ensure prompt notification of a high respiratory rate condition.
13.12 INSPIRATION TOO LONG alarm

The INSPIRATION TOO LONG alarm, active only when Vent Type is
INVASIVE, indicates the inspiratory time of a spontaneous breath
exceeds this time limit:
(1.99 + 0.02 x IBW) seconds (adult and pediatric circuits)
(1.0 + 0.10 x IBW) seconds (neonatal circuits)
where IBW is the current setting for ideal body weight in kg.
When the ventilator declares an INSPIRATION TOO LONG alarm, the
ventilator terminates inspiration and transitions to exhalation. The
INSPIRATION TOO LONG alarm applies only to spontaneous breaths.
You cannot set or disable the INSPIRATION TOO LONG alarm.
Because leaks (in the patient circuit, around the endotracheal tube
cuff, or through chest tubes) and patient-ventilator mismatch can
affect accurate exhalation detection, the INSPIRATION TOO LONG
alarm can act as a backup method of safely terminating inspiration.
If the INSPIRATION TOO LONG alarm occurs frequently, check for
leaks and ensure ESENS and rise time % are properly set.
13.13 Low circuit pressure alarm

The low circuit pressure (3P PEAK) alarm indicates the measured
maximum airway pressure during the current breath is less than or
equal to the set alarm level during a non-invasive inspiration or
during a VC+ inspiration.
The 3P PEAK alarm is active for mandatory and spontaneous breaths,
and is present only when Vent Type is NIV or Mandatory Type is VC+.
During VC+, if the PEEP level is set to 0 cmH2O, the 3P PEAK alarm can
be turned OFF. The 3P PEAK alarm can always be turned OFF during
Alarms
NIV. The 4P PEAK alarm limit cannot be set to a value greater than or
equal to the 2P PEAK alarm limit.
Warning
Because the VC+ pressure control algorithm does not allow
the target inspiratory pressure to fall below PEEP + 5 cmH2O,
attempting to set the 4PPEAK alarm limit at or below this level
will turn the alarm off.
Whenever PEEP is changed, 3P PEAK is set automatically to its New

Patient value, PEEP + 6 cmH2O.
There are no alarms dependent upon 3P PEAK, and the 3P PEAK alarm
does not depend on other alarms.
13.14 Low delivered O2% alarm

The low delivered O2% (O2%) alarm indicates the measured O2%
during any phase of a breath is at or below the error percentage
below the O2% setting, or less than or equal to 18%, for at least 30
seconds. Although the ventilator automatically sets the O2% alarm,
you can disable the oxygen sensor. (The error percentage is 12%
below setting for the first hour of ventilator operation, 7% below
setting after the first hour of operation, and an additional 5% below
setting for the first four minutes following a increase in the setting.)
The ventilator automatically adjusts the O2% alarm limit when
O2% changes due to apnea ventilation, circuit disconnect, or a
NO O2/AIR SUPPLY alarm. The O2% alarm is disabled during a safety
valve open (SVO) condition. The ventilator checks the O2% alarm
against the measured oxygen percentage at 1-second intervals.
The O2% alarm can detect malfunctions in ventilator gas delivery or
the oxygen monitor, and can ensure the patient is adequately
oxygenated. The O2% alarm limit is automatically adjusted during
apnea ventilation, patient circuit disconnect, or low gas inlet
pressures because O2% changes are expected under those
circumstances. The ventilator declares a O2% alarm after
30 seconds to eliminate nuisance alarms due to transient O2%
delivery variations. You can view the O2% measured by the oxygen
sensor by touching the More Patient Data button on the upper GUI
screen.
Alarms
13.15 Low exhaled mandatory tidal volume alarm

The low exhaled mandatory tidal volume (3VTE MAND ) alarm
indicates the measured exhaled mandatory tidal volume is less than
or equal to the 3VTE MAND limit. The 3VTE MAND alarm is updated
whenever a new measured value of exhaled mandatory tidal volume
is available.
The 3VTE MAND alarm can detect an obstruction, a leak during
volume ventilation, or a change in compliance or resistance during
pressure-based ventilation (that is, when the same pressure is
achieved but tidal volume decreases). There are separate alarms for
mandatory and spontaneous exhaled tidal volumes for use during
SIMV, SPONT, and BILEVEL. The ventilator phases in a change to the
3VTE MAND alarm immediately to ensure prompt notification of a low
exhaled tidal volume condition.
13.16 Low exhaled spontaneous tidal volume alarm

The low exhaled spontaneous tidal volume (3VTE SPONT ) alarm
indicates the measured exhaled spontaneous tidal volume is less
than or equal to the 3VTE SPONT limit. The 3VTE SPONT alarm is
updated whenever a new measured value of exhaled spontaneous
tidal volume is available.
The 3VTE SPONT alarm can detect a leak in the patient circuit or a
change in the patient’s respiratory drive during a single breath. The
3VTE SPONT alarm is based on the current breath rather than on an
average to detect changes as quickly as possible. There are separate
alarms for mandatory and spontaneous exhaled tidal volumes for
use during SIMV. The ventilator phases in a change to the 3VTE SPONT
alarm limit immediately to ensure prompt notification of a low
exhaled tidal volume condition.
Alarms
13.17 Low exhaled total minute volume alarm

The low exhaled total minute volume (VE TOT )alarm indicates the
measured minute volume (for mandatory and spontaneous breaths)
is less than or equal to the set VE TOT limit. The VE TOT alarm is
updated whenever a new value for exhaled minute volume is
calculated. You cannot turn off the VE TOT alarm.
The VE TOT alarm can detect a leak or obstruction in the patient
circuit, a change in compliance or resistance, or a change in the
patient's breathing pattern. The VE TOT alarm can also detect too-
small tidal volumes, which could lead to hypoventilation and
hypoxia (oxygen desaturation).
The ventilator phases in changes to the V E TOT alarm limit
immediately to ensure prompt notification of prolonged low tidal
volumes.
13.18 PROCEDURE ERROR alarm

The ventilator declares a PROCEDURE ERROR alarm if ventilator is
powered up (either by turning on the power switch or following a
power loss of at least 5 minutes) and detects a patient attached
before Ventilator Startup has been completed. Until ventilator
settings are confirmed, the ventilator annunciates a high-urgency
alarm and enters safety ventilation.
The PROCEDURE ERROR alarm is intended to require you to confirm
ventilator settings whenever ventilator power is restored, in case a
new patient is attached to the ventilator. Safety ventilation is an
emergency mode of ventilation providing ventilation according to
displayed settings until you have confirmed ventilator settings, and
is not intended for long-term patient ventilation.
Alarms
This page is intentionally blank.

Urgent Field Safety Notice Puritan Bennett™ 840 Ventilator - Operator's Manual Update For Loss of GUI Display

Uploaded by

Copyright:

Available Formats

Urgent Field Safety Notice Puritan Bennett™ 840 Ventilator - Operator's Manual Update For Loss of GUI Display

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Urgent Field Safety Notice Puritan Bennett™ 840 Ventilator - Operator's Manual Update For Loss of GUI Display

Uploaded by

Copyright:

Available Formats

URGENT FIELD SAFETY NOTICE

DAY MONTH, 2014

Dear Valued Customer,

Loss of GUI display

• Verify the patient’s respiratory and physiological stability.

Important Safety Reminders

• Patients on life-support equipment should be appropriately monitored by medical personnel

Red loss of GUI indicator: The ventilator has detected a

Puritan Bennett™ 800 Series Ventilator System Operator’s Manual 10132669A00

This chapter discusses the ventilator’s alarm handling

13.1 Alarm handling

Alarm annunciations include a level of urgency, which is an estimate

Table 13-1: Alarm urgency levels

Urgency Visual Audible

High: Red High-priority If all high-urgency alarm

Medium: Yellow Medium- If all medium-urgency alarm

Low: Yellow, Low-priority If all low-urgency alarm

Normal: Green, None Not applicable.

13.1.1 Alarm messages

The base message identifies

The two highest-

Touch flashing MORE ALARMS

Figure 13-1. Alarm message format (upper GUI screen)

The following rules define how alarm messages are displayed:

• The urgency level of a primary alarm is equal to or greater than

13.1.2 Alarm summary

Table 13-2: Alarm summary

AC POWER Low Operating on Prepare Power switch on, AC

Table 13-2: Alarm summary

APNEA Medium Apnea Check The set apnea

CIRCUIT High No Check Ventilator has

High No Check Ventilator detects

Table 13-2: Alarm summary

COMPLIANCE Low Compliance Inspired Compliance volume

COMPRESSOR Low No No Compressor ready

Low No Ventilator turns off

Low No Compressor ready

Low N/A Replace Alarm occurs when

Table 13-2: Alarm summary

DEVICE Low Breath Service Background checks

Low Breath Service POST has detected a

Medium Ventilation Replace & Background checks

Table 13-2: Alarm summary

DEVICE Medium Ventilation Replace & Background checks

Medium Breath Background checks

Medium Ventilation Background checks

Medium Breath Check Background checks

Table 13-2: Alarm summary

DEVICE Medium Ventilation Replace & Background checks

High Breath Background checks

High Unable to Check Background checks

High Ventilation Replace & Background checks

Table 13-2: Alarm summary

DEVICE High Ventilation Replace & Background checks

High Ventilation Replace & Background checks

High Breath Check Background checks

High Ventilation Check Background checks

Table 13-2: Alarm summary

DEVICE High Ventilation Replace & Background checks