BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 11 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1082702 · Received July 23, 2008

    Report

    Report Number
    3015876-2008-00820
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    DRO
    PMA / PMN Number
    K951593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE THERAPY CONNECTOR WAS WORN AND THE DEVICE INTERMITTENTLY ALARMED "ENERGY NOT DELIVERED CHECK PADDLES AND ELECTRODES" AFTER CHARGING THE DEFIBRILLATOR AND ATTEMPTING TO DELIVER A SHOCK INTO A PATIENT SIMULATOR, INDICATING AN OPEN CIRCUIT IN THE THERAPY CABLE/CONNECTOR. FURTHER INSPECTION OF THE DEVICE THERAPY CONNECTOR DETERMINED THAT ROOT CAUSE FOR THE INTERMITTENT OPERATION WAS WORN LOW VOLTAGE PIN SOCKETS. THE THERAPY CONNECTOR WAS REPLACED AND THE PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHILE PERFORMING A DAILY TEST, THE DEVICE ALARMED AND GAVE A MESSAGE INDICATING THAT THE THERAPY CONNECTOR WAS NOT CONNECTED AFTER THE DEVICE SHOCKED INTO A PATIENT SIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 11 DEFIBRILLATOR/PACEMAKER DRO PHYSIO-CONTROL, INC 11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA