BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19205381 · Received April 29, 2024

    Report

    Report Number
    3008642652-2024-04436
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    March 23, 2024
    Report Date
    April 29, 2024
    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

    EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON¿T POWER UP) HAS BEEN CONFIRMED DUE TO A DEFECTIVE U104 PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD, CAUSING FAULT. THE ROOT CAUSE FOR THE DEFECTIVE U104 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 U.S. DISTRIBUTOR REPORTED THAT A MONITOR WILL NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981357 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown