BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    MDR report key: 3141289 · Received June 3, 2013

    Report

    Report Number
    3015876-2013-00464
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE DEVICE AND VERIFIED THE FAILURE. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE UNDER WARRANTY. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL COMPLETED THE DEVICE EVALUATION AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE INTERNAL HLC BATTERIES WERE DEPLETED AND THE DEVICE WOULD NOT TURN ON. AFTER EXTENSIVE TESTING IN THE FAILURE ANALYSIS CENTER, THE CAUSE OF THE REPORTED POWER FAILURE COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS THE SERVICE WRENCH, CHARGE-PAK AND ATTENTION ICONS ILLUMINATED. THEREFORE, THE DEVICE COULD NOT PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244396 LIFEPAK EXPRESS(R) DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC EXPRESS

    Patients

    Seq Age Sex Outcome Treatment
    1