BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX

    MDR report key: 2931798 · Received October 17, 2012

    Report

    Report Number
    2931798
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    GCX CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE GCX MOUNTING BRACKET ON THE SPACELAB HOUSING BROKE AND THE HOUSING AND THE MODULES FELL. THE UNIT IS VERY HEAVY AND IS LOCATED ABOVE THE PATIENT'S HEAD. THE NURSE WAS UNSURE OF WHAT CAUSED THE MOUNT TO BREAK AS NO ONE WAS MOVING OR TOUCHING IT AT THE TIME IT GAVE WAY. THIS IS THE 4TH MODULE BRACKET TO BREAK IN THE CRITICAL CARE UNIT. THE MOUNTING ARMS THAT SUPPORTS THE SPACELAB MODULE HOUSING BROKE JUST ABOVE THE HOUSING AT THE SWIVEL POINT.THE SERVICE REP FOR GCX CORPORATION CAME TO THE FACILITY AND REINFORCED THE CONNECTION BETWEEN THE ARM AND THE MONITOR WITH PLASTIC TIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCX MONITOR, PHYSIOLOGICAL, MOUNTING ARM MHX GCX CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *