BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121031 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00358
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION ELECTRODE BELT HAVE BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE A BROKEN WIRE IN THE TRUNK CABLE. THE DRIVEN GROUND WIRE WAS PULLED INTO THE OUTER INSULATION. THE ROOT CAUSE OF THE BROKEN WIRES APPEARS TO BE MISUSE. THERE WERE CUTS NOTED ON THE TRUNK CABLE. ALSO, THE CABLE LOOKED TO HAVE BEEN STRETCHED. BOTH THERAPY ELECTRODES WERE HEAVILY CREASED. THE ELECTRODE BELT WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE OPEN CONNECTION IN THE TRUCK CABLE. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT EXPERIENCED ANY PROBLEMS WITH IT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE DRIVEN GROUND RELAY WAS OPEN. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT EXPERIENCE ANY PROBLEMS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA