LIFEPAK 20 and LIFEPAK 20e External
Defibrillator/Monitors by
Physio-Control Inc.: Class I Recall Due To Power Supply
Failure
Audience: Emergency Medicine, Cardiology, Risk Manager
ISSUE: A failure on the power supply assembly can result in
either "No
DC power" or "No DC or AC power". A failure of DC (battery)
power can
result in the inability to deliver defibrillation therapy if
the
device
will not turn on using DC (battery) power and no AC (line)
power is
available.
BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e
defibrillator/monitor is
designed for use by trained medical personnel in hospitals and
clinic
settings to monitor patient heart rhythms and to treat
patients
experiencing cardiac arrest. Approximately 42,943 devices
were
distributed worldwide between September 16, 2002 and September
27,
2007.
These devices were manufactured from July 31, 2002 to September
19,
2007.
RECOMMENDATION: All affected power supplies will be updated.
Customers
are advised to keep the defibrillators in service and
follow
recommended
daily Operator Checklist steps while service updates are
scheduled.
See
Recall Notice for contact information.
Read the MedWatch safety alert, including a link to the FDA
Class I
Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm
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