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MedWatch - The FDA Safety Information and Adverse
Event Reporting Program
Medtronic, Inc. and FDA advised healthcare professionals of a Class 1
recall of the LIFEPAK 500 automated external defibrillators (AEDs). The
AED may continue to display a "connect electrodes" message and
may not analyze the patient's heart rhythm even when the electrodes are
properly connected. Failure to analyze the patient's heart rhythm will
inhibit defibrillation, if it is needed. This action affects 1,924 first-generation
LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately
1 percent of LIFEPAK 500 AEDs currently in use worldwide. This action
does not affect any other LIFEPAK 500 AEDs currently produced, or any
other LIFEPAK product. The company will update or upgrade customer devices
at no charge by March 31, 2005. The affected AEDs may remain in service
and customers are currently being contacted with recommendations for use
and replacement schedules.
Read the complete MedWatch 2005 safety summary, including links to the
FDA Recall notice and Firm Press Release, at
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#LIFEPAK
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