BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1061751 · Received June 13, 2008

    Report

    Report Number
    3015876-2008-00601
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT PASS THE USER TEST AND WAS UNABLE TO CHARGE. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA