BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5191728 · Received October 30, 2015

    Report

    Report Number
    3008642652-2015-06854
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ZOLL MANUFACTURING 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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL THERAPY ELECTRODES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING, SPECIFICALLY THE TE RECOGNITION TEST. UPON INVESTIGATION, THERE WAS AN OPEN ALONG THE FRONT PULSE WIRE INSIDE THE TRUNK CABLE. THE CAUSE OF THE TEST FAILURE IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN PULSE WIRE IS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT THE THERAPY ELECTRODES WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723178 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1