BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 24896653 · Received April 16, 2026

    Report

    Report Number
    3008642652-2026-03678
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE DISPLAYED) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR FAILED TO INITIALIZE ARBITRARY WAVEFORM GENERATOR (AWG). ADDITIONALLY, A SERVICE CODE 102 (CHARGE PROFILE FAULT) WAS DISPLAYED. THE CAUSE FOR THE SERVICE CODE 102 WAS ISOLATED TO CONTAMINATION ON THE PINS OF PCA JUMPER J1000. ROOT CAUSE OF THE FAILED AWG COULD NOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. LIFEVEST PATIENT INSTRUCTIONS FOR USE REMIND AND WARN PATIENTS NOT TO EXPOSE THE LIFEVEST ELECTRONIC COMPONENTS TO LIQUIDS. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 0

    A US DISTRIBUTOR RETURNED A MONITOR AND REPORTED BEING UNABLE TO COMPLETE INCOMING FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965223 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown