BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTING BRACKET

    MDR report key: 11391823 · Received March 1, 2021

    Report

    Report Number
    11391823
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 12, 2021
    Report Date
    February 23, 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

    SCREWS IN THE BRACKET THAT WERE PRE ASSEMBLED CAME LOOSE, AND THE MONITOR COULD HAVE FALLEN OFF THE MOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288528 MOUNTING BRACKET STAND, INFUSION FOX GCX CORPORATION 38532 080320

    Patients

    Seq Age Sex Outcome Treatment
    1