BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 16511898 · Received March 9, 2023

    Report

    Report Number
    3008642652-2023-02221
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 9, 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

    DURING INVESTIGATION FOR AN UNRELATED EVENT, A REPORTABLE MALFUNCTION WAS FOUND. THE MONITOR WAS UNABLE TO POWER ON. THE CAUSE FOR FAILURE WAS ISOLATED TO A DEFECTIVE U104 PXA COMPONENT. THE ROOT CAUSE FOR THE DEFECTIVE U104 PXA PROCESSOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 0

    DURING INVESTIGATION OF THE MONITOR FOR AN UNRELATED ISSUE, A REPORTABLE MALFUNCTION WAS FOUND. THE MONITOR WAS UNABLE TO COMPLETE ESSENTIAL PERFORMANCE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708227 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown