BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX POLYMOUNT ROLL STAND

    MDR report key: 28778 · Received November 13, 1995

    Report

    Report Number
    3023750-1995-00002
    Event Type
    Malfunction
    Date Received
    November 13, 1995
    Date of Event
    October 24, 1995
    Report Date
    November 13, 1995
    Manufacturer
    GCX CORP.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A HOSP REPORTED THAT ON TWO OCCASIONS AN ALUMINUM COMPONENT ON A PT MONITOR ROLL STAND BROKE, CAUSING THE MONITOR TO FALL A SHORT DISTANCE. NO PT INJURY OR USER INJURY OCCURRED AS A RESULT. THERE WAS NO DAMAGE CAUSED TO THE PT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCX POLYMOUNT ROLL STAND MOUNTING SYSTEM DRT GCX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *