BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23142878 · Received September 25, 2025

    Report

    Report Number
    3008642652-2025-09205
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 19, 2025
    Report Date
    September 25, 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 (ECG ELECTRODES NON-FUNCTIONAL) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT HAD NON-FUNCTIONAL ECGS. THE CAUSE FOR WAS ISOLATED TO THE BROWN (LEAD 1-) WIRE IN THE CABLE CONNECTING ECG 1 AND ECG 2 IS BROKEN NEAR THE JST CONNECTOR. THE ROOT CAUSE FOR THE BROKEN WIRE WAS EXCESSIVE FORCE. THERE WAS NO ADVERSE EVENT THAT 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
    1641412 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown