BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTING BRACKET

    MDR report key: 12420974 · Received September 3, 2021

    Report

    Report Number
    12420974
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 16, 2021
    Report Date
    August 26, 2021
    Manufacturer
    GCX CORPORATION
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MOUNTING SCREWS FOR THE GCX MOUNT FOR THE MASIMO MONITOR WITH BAR CODE SCANNER WERE MISSING, MONITOR COULD HAVE FALLEN OFF THE WALL MOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319690 MOUNTING BRACKET STAND, INFUSION FOX GCX CORPORATION 38532 080320

    Patients

    Seq Age Sex Outcome Treatment
    1