BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX

    MDR report key: 1360068 · Received April 1, 2009

    Report

    Report Number
    1360068
    Event Type
    Malfunction
    Date Received
    April 1, 2009
    Date of Event
    March 14, 2009
    Report Date
    March 25, 2009
    Manufacturer
    GCX CORP.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE PATIENT CUBICLE THE GCX MOUNT THAT IS TO HOLD THE PHILLIPS MONITOR IN PLACE FELL DOWN SUDDENLY AND UNPREDICTABLY, STRIKING THE EMPLOYEE ON THE BRIDGE OF HER NOSE. WHEN THE GCX MOUNT GAVE WAY, IT CRASHED DOWN ONTO AND CRUSHED AN APPROXIMATELY 10 INCH OSCILLATING FAN WHICH DECREASED THE IMPACT OF THE MOUNT AND MONITOR ON THIS EMPLOYEE'S NOSE. OTHERWISE THIS BLOW COULD HAVE BEEN DEVASTATING TO THE EMPLOYEE. THE DEVICE IS AVAILABLE FOR ON-SITE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCX WALL MOUNT DRT GCX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR