BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4230956 · Received October 15, 2014

    Report

    Report Number
    3008642652-2014-03303
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 13, 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 SUMMARY OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (TES NON-FUNCTIONAL) WAS CONFIRMED. AS RECEIVED THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. UPON EVALUATION, THERE WAS AN OPEN ALONG THE REAR PULSE WIRE IN THE TRUNK CABLE. THE CAUSE OF THE FAILURE WAS ISOLATED TO THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) TO REPORT THAT THE THERAPY ELECTRODES (TE) WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652759 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA