BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0886-2007 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-0886-2007
    Event Number
    37692
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MJK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2007
    Posted
    July 4, 2007
    Terminated
    May 4, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.

    Quantity

    26418