BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212035 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00172
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 30, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (SERVICE CODE 105; CAN COMM TIMEOUT FAULTS) HAVE BEEN INVESTIGATED. UPON EVALUATION THE TRUNK CABLE CONNECTOR WAS DAMAGED, THUS GENERATING CAN COMM TIMEOUT FAULTS AND SERVICE CODE 105. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT. NO PROBLEMS WERE FOUND WITH THE PATIENT'S MONITOR.

    Description of Event or Problem · 1

    A REVIEW OF A (B)(6) MALE PATIENT'S DOWNLOAD REVEALED SEVERAL CAN COMM TIMEOUT FAULTS AND SERVICE CODE 105. THE PATIENT WAS CONTACTED BY ZOLL CUSTOMER SUPPORT AND ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR