BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX

    MDR report key: 258862 · Received January 14, 2000

    Report

    Report Number
    258862
    Event Type
    Malfunction
    Date Received
    January 14, 2000
    Date of Event
    January 6, 2000
    Report Date
    January 7, 2000
    Manufacturer
    GCX CORPORATION
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GCX POLYMOUNT BRACKET SEPARATED WHEN SCREW FELL OUT AND A MONITOR WEIGHING APPROXIMATELY 55 POUNDS FELL. THE MONITOR WAS CAUGHT AND HELD BY A NURSE AND WAS ALSO HELD BY ONE ARM OF THE METAL BRACKET THAT WAS BENT BY THE WEIGHT OF THE MONITOR. THE SCREWS USED TO MOUNT THIS MONITOR WERE INSTALLED FLAT HEAD TOWARD THE BED. WHEN THE CAP STYLE BOLT ON TOP LOOSENS, THE SCREWS FALL OUT. THERE IS THE POTENTIAL TO CAUSE MAJOR PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCX POLYMOUNT BRACKET IOY GCX CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other