BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 21160690 · Received January 15, 2025

    Report

    Report Number
    3008642652-2025-00518
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 110/107/104) WAS CONFIRMED DUE TO CONTAMINATION ON THE PINS OF PCA JUMPER J1000 AND J101 ON THE C/A BOARD. 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. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 0

    A US DISTRIBUTOR RETURNED A MONITOR AND REPORTED MONITOR WAS DISPLAYING SERVICE CODES 110, 104, AND 107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976907 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