BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23571176 · Received November 17, 2025

    Report

    Report Number
    3008642652-2025-11157
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005036
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) WAS CONFIRMED DUE TO A LOOSE BUS BAR INSIDE OF THE BATTERY.THE ROOT CAUSE OF THE LOOSE BUSBAR CANNOT BE PO.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A BATTERY WAS UNABLE TO POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288548 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown