Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0887-2007

Batteries used with the LIFEPAK 20 defibrillator/monitor

Physio Control, Inc. / initiated 2007-03-30 / Terminated

Medtronic Emergency Response Systems, Inc. began a recall of Batteries used with the LIFEPAK 20 defibrillator/monitor on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0887-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
Product
Batteries used with the LIFEPAK 20 defibrillator/monitor
Product code
MJK Dna Probe, Trichomonas Vaginalis
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.
FDA root cause
Other
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.
Quantity in commerce
3002
Distribution
Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
Product codes and lots
Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266