BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1082150 · Received July 25, 2008

    Report

    Report Number
    3015876-2008-00840
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 26, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CODE, AND WHILE THE DEVICE WAS CONNECTED TO A PATIENT, THE DEVICE STATED "CONNECT ELECTRODES". AN AMBULANCE THEN ARRIVED ON THE SCENE WITH A MANUAL DEFIBRILLATOR TO TAKE OVER THE PATIENT CARE. THERE WAS NO AVERSE EVENT ASSOCIATED WITH THIS FAILURE.

    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