BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23184050 · Received September 30, 2025

    Report

    Report Number
    3008642652-2025-09384
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 30, 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 (ADD GEL/REPLACE BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE WAS ISOLATED TO BROKEN LEAD 1- AND LEAD 2- WIRES NEAR THE JST CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED WIRES COULD NOT BE POSITIVELY IDENTIFIED THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A PATIENT WAS EXPERIENCING ADD GEL/REPLACE BELT MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215113 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown