Company: Physio-Control, Inc.
Date of Enforcement Report:6/42014
Class lI:
PRODUCT
LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Recall Number Z-1660-2014
REASON
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 1000 defibrillator causes the Readiness Display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the “OK” symbol is present.
RECALLING FIRM/MANUFACTURER
Physio-Control, Inc. Redmond, WA on 5/9/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
96,261 total; 40,818 within the US and 55,281 outside US.
DISTRIBUTION
Nationwide and Internationally
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