BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 17331565 · Received July 17, 2023

    Report

    Report Number
    3008642652-2023-06924
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 17, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 THE MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A DEFECTIVE U104 PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE DEFECTIVE U104 PXA PROCESSOR COULD NOT BE POSITIVELY IDENTIFIED. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE MONITOR MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A MONITOR WILL NOT POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488429 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown