BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 20515052 · Received October 23, 2024

    Report

    Report Number
    3008642652-2024-10591
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 (WILL NOT POWER ON) WAS CONFIRMED DUE TO A DEFECTIVE U104 PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD, CAUSING A TARGET COMMUNICATION ERROR. 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 US DISTRIBUTOR REPORTED THAT A MONITOR WILL NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361719 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