BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 21764066 · Received April 3, 2025

    Report

    Report Number
    3008642652-2025-03491
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 29, 2025
    Report Date
    April 3, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT ADDRESS AND TELEPHONE: ZOLL SERVICES, LLC 121 GAMMA DRIVE. PITTSBURGH, PA 15238 PHONE: 800-543-3267 USA DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT RUN DETECT AND TREAT TESTING DUE TO FUNCTIONAL ISSUE) WAS DUE TO THE MONITOR'S ELECTRODE BELT RECEPTACLE WAS PHYSICAL. CORRECTION: MONITOR WAS REPAIRED AND REFURBISHED. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE POSITIVELY IDENTIFIED. THERE

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A MONITOR CANNOT RUN DETECT AND TREAT TESTING DUE TO FUNCTIONAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654757 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