BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23451474 · Received November 3, 2025

    Report

    Report Number
    3008642652-2025-10617
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005135
    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 (ECGS NON-FUNCTIONAL) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT UNABLE TO COMPLETE AN ECG FALLOFF TEST. UPON INVESTIGATION THE ELECTRODE BELT LEAD 1- WIRE WAS BROKEN NEAR THE JST CONNECTOR. THE ROOT CAUSE FOR BROKEN CABLE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED 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
    1067536 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown