BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HWD 1000 SYSTEM

    MDR report key: 19414555 · Received May 29, 2024

    Report

    Report Number
    3008642652-2024-05552
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    March 25, 2024
    Report Date
    May 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

    DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NON-FUNCTIONAL) WAS CONFIRMED. UPON INVESTIGATION, THE REAR RESPONSE BUTTON WAS NOT FUNCTIONAL. THE CAUSE FOR THE FAILURE WAS CAUSED BY THE REAR RESPONSE BUTTON CENTER/ DOME WAS OFF CENTER. THE ROOT CAUSE OF THE OFF CENTER DOME CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A MONITOR'S RESPONSE BUTTONS WERE NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838207 HWD 1000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION HWD 1000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown