BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1112138 · Received August 6, 2008

    Report

    Report Number
    3015876-2008-00869
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE BATTERY, AND THEN OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO USE THE DEVICE ON A PT, THE DEVICE POWERED ITSELF DOWN. THE AMBULANCE THEN ARRIVED AND USED A DIFFERENT DEVICE TO SHOCK THE PT. THE PT WAS NOT RESUSCITATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK