BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 21197171 · Received January 21, 2025

    Report

    Report Number
    3008642652-2025-00711
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 16, 2025
    Report Date
    January 21, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM (TES NON-FUNCTIONAL) WAS CONFIRMED DUE TO THE ELECTRODE BELT¿S WHITE 26 AWG PULSE WIRE OF THE TRUNK CABLE BEING BROKEN, CAUSING THE THERAPY ELECTRODES TO NOT RECOGNIZE DURING TESTING. THE BELT DID NOT PASS FALLOFF TESTING. THE ROOT CAUSE FOR BROKEN WIRE WAS UNABLE TO BE POSITIVELY IDENTIFIED. THE ELECTRODE BELT IS DESIGNED TO MEET THE MECHANICAL REQUIREMENTS OF IEC 60601-1. 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 THERAPY ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708529 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown