BEUDAMED
    FDA Adverse Event Summary report: N

    FLUOROSCOPIC X-RAY UNIT

    MDR report key: 17285 · Received October 31, 1994

    Report

    Report Number
    MW1003862
    Date Received
    October 31, 1994
    Date of Event
    July 20, 1994
    Report Date
    October 28, 1994
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    SERVICE PEOPLE IN TO DO ROUTINE WORK ON THIS UNIT DISCOVERED THAT WHEN THE LATERAL TUBE FOOT SWITCH WAS REPLACED, THE UNIT CONTINUED TO X-RAY. NORMALLY, THE ROOM LIGHTS DARKEN WHEN THE UNIT IS ON AND WHEN THE LIGHTS COME BACK ON IT MEANS THE UNIT IS OFF AND THERE IS NO IMAGE ON THE SCREEN. EVEN THOUGH THE DEVICE WAS STAYING ON WHEN IT SHOULD HAVE BEEN OFF, THE LIGHTS AND SCREEN FUNCTIONED AS THOUGH THERE WAS NOTHING WRONG WITH THE UNIT. WHEN THE USER SWITCHED FROM THE LATERAL TUBE TO THE A TO P TUBE (VERTICAL TUBE) THE LATERAL TUBE WOULD DISENGAGE. ALSO IF THE IMAGE INTENSIFIER WAS PLACED IN A PARK POSITION, THE LATERAL TUBE WOULD TURN OFF. INVESTIGATION OF FLUORO TIMES SHOWED THAT THESE EVENTS OCCURRED ONLY ONE WAY. THE RPTR STATED THAT IT APPEARS ONLY ONE PT RECEIVED DOUBLE FLUORO TIME; 10 MINUTES OF FLUORO TIME INSTEAD OF FIVE. THE RPTR STATED THAT THIS INCIDENT WAS INVESTIGATED IN 8/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY UNIT JAA GENERAL ELECTRIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 *