BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1953963 · Received December 16, 2010

    Report

    Report Number
    3015876-2010-01383
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE RPTR TECHNICAL ASSISTANCE AND ADVISED PURCHASING A REPLACEMENT DEVICE. F/U WITH THE CALLER FOUND THAT THE FACILITY REMOVED THE DEVICE FROM SERVICE AND WILL BE TRADING IN IT FOR A CREDIT TOWARDS A PURCHASE OF A REPLACEMENT DEFIBRILLATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED ALL THREE (ATTENTION, CHARGE PAK AND WRENCH) ICONS AND IT WOULD NOT POWER ON. THE CHARGE PAK (INTERNAL BATTERY CHARGER) WAS REPLACED BUT THE DEVICE WAS DEAD. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA