LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.
FDA Recall Z-0886-2007 · Posted 2007-07-04
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Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMJK
Date Initiated2007-03-30
Date Terminated2011-05-04
Product Quantity26418
Reason for Recall
Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
Firm Action
Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.
Root Cause
Other
Distribution Pattern
Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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