BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 17248759 · Received July 3, 2023

    Report

    Report Number
    3008642652-2023-06474
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 3, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 (ADJUST BELT AND CHECK PAD MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO THE DRVN -GRD WIRE IN TRUNK CABLE MEASURES OPEN. THE ROOT CAUSE FOR THE OPEN WIRE WAS EXCESSIVE FORCE. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A PATIENT WAS EXPERIENCING CHECK THERAPY PAD AND ADJUST BELT MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26715 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown