BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1024185 · Received March 26, 2008

    Report

    Report Number
    3015876-2008-00225
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K955854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE BATTERY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED BATTERY ASSEMBLY AND OBSERVED THAT ONE OR MORE CELLS VENTED, LEAVING RESIDUE INSIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON BATTERY POWER. THERE WAS NO PT INVOLVEMENT REPORTED 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