BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1070706 · Received July 2, 2008

    Report

    Report Number
    3015876-2008-00735
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 11, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE UNIT WAS FULL OF WATER, CAUSING THE DEVICE NOT TO POWER ON. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION, AS THE CUSTOMER HAS DECLINED REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA