BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23245181 · Received October 8, 2025

    Report

    Report Number
    3008642652-2025-09693
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 8, 2025
    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 · 0

    DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL ECGS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THIS FAILURE WAS DUE TO THE LEAD 1- WIRE BROKEN NEAR THE JST CONNECTOR ON THE ECG C AND D CABLE. THE ROOT CAUSE FOR THE BROKEN WIRES COULD NOT BE POSITIVELY IDENTIFIED. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE DAMAGED ELECTRODE BELT.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT AN ELECTRODE BELT HAD NON-FUNCTIONAL ECGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584161 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown