BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23581982 · Received November 18, 2025

    Report

    Report Number
    3008642652-2025-11189
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 18, 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

    EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 107) WAS CONFIRMED. THE MULTIPLE ABNORMAL SHUTDOWNS WERE DUE TO A DEFECTIVE PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE DEFECTIVE PXA PROCESSOR COULD NOT BE POSITIVELY IDENTIFIED. 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 A SERVICE CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989155 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