BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX WALL BRACKET, VARIABLE HEIGHT

    MDR report key: 1016198 · Received March 18, 2008

    Report

    Report Number
    1220063-2008-00008
    Event Type
    Malfunction
    Date Received
    March 18, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 17, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE SCREWS FROM THE GCX MOUNTING BRACKET CAME LOOSE CAUSING DRAEGER MONITOR TO FALL FORWARD. THE GCX MOUNTING BRACKET IS A NON DRAEGER PRODUCT. THE DRAEGER DEVICE DID NOT CAUSE THIS EVENT. WE HAVE NOTIFIED THE MOUNTING BRACKET MFR (GCX CORP) OF THIS EVENT FOR FURTHER INVESTIGATION AND POSSIBLE CORRECTIVE ACTION BY GCX CORP. DRAEGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A PT A NURSE TOUCHED THE DRAEGER MONITOR WHICH FELL FORWARD AND HIT HER IN THE FACE. SHE SUFFERED MINOR CUTS AND BRUISING AND HAD TO BE RELIEVED OF HER DUTIES. A FAULT WAS DIAGNOSED WITH GCX BRACKET DUE TO THE TENSION BOLTS WORKING LOOSE CAUSING THE 5 INCH PLUNGE PLATE TENSIONING MECHANISM TO BECOME LOOSE AND ALLOWING THE DRAEGER MONITOR TO FALL. THE DRAEGER MONITOR WAS MOUNTED ON THE GCX BRACKET. THE NURSE RETURNED TO DUTY THE FOLLOWING DAY. THE BRACKET WAS TENSIONED ON INSTILLATION, BUT SUBSEQUENTLY WORKED LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCX WALL BRACKET, VARIABLE HEIGHT PATIENT MONITOR MONITORING BRACKET DRT DRAEGER MEDICAL SYSTEMS, INC. (IT/M) S1-0021-19C P030357

    Patients

    Seq Age Sex Outcome Treatment
    1