BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2231391 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00285
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 25, 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 BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE/WIRES EXPOSED) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT CABLE WAS DAMAGED AT THE DISTRIBUTION NODE (DN). THE DN TO REAR 2 WIRE THERAPY ELECTRODE PORTION OF THE CABLE WAS PULLED FROM THE STRAIN RELIEF AT THE DN. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED BELT CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE PATIENT TO EXCHANGE HIS ELECTRODE BELT. THE PATIENT'S DOWNLOADS WERE SHOWING NUMEROUS GEL RELEASE FLAGS BUT NO ARRHYTHMIA ALARMS IN CONJUNCTION WITH THE EVENTS. THE PATIENT WAS PROVIDED WITH A REPLACEMENT 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 63 YR