BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4080959 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02116
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 OR WIRES EXPOSED) WAS CONFIRMED. UPON INVESTIGATION THE WHITE (DRIVEN GRND) WIRE WAS BROKEN AT THE TRUNK CABLE CONNECTOR. THE CAUSE WAS PHYSICAL DAMAGE TO THE TRUNK CABLE CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS UNABLE TO BE POSITIVELY DETERMINED, BUT LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S SON CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CONNECTOR ON THE ELECTRODE BELT WAS DAMAGED AND WIRES WERE EXPOSED. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400701 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR