BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL ELECTRIC PORTABLE X-RAY UNIT

    MDR report key: 112763 · Received July 16, 1997

    Report

    Report Number
    112763
    Event Type
    Malfunction
    Date Received
    July 16, 1997
    Date of Event
    December 23, 1996
    Report Date
    January 8, 1997
    Manufacturer
    GENERAL ELECTRIC CO
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 17 YEAR OLD FEMALE WAS ADMITTED ON 12/23/96 FOR THE PURPOSE OF REMOVAL OF HARDWARE FROM THE THORACOLUMBAR SPINE. SHE HAD A HISTORY OF IDIOPATHIC SCOLIOSIS AND HAD UNDERGONE BOTH POSTERIOR AND ANTERIOR SPINAL FUSIONS. FOLLOWING THE REMOVAL OF THE RODS AND HOOKS, THE SURGEON REQUESTED INTRAOPERATIVE X-RAYS IN ORDER TO ESTABLISH THAT THERE WAS NO HARDWARE IN THE WOUND. THE RADIOLOGY TECHNICIAN SECURED THE FIRST FILM USING THE PORTABLE X-RAY UNIT, WHICH WAS TOO LIGHT; THEREFORE SHE ADJUSTED THE FACTORS. WHEN TAKING THE SECOND FILM, USING THE SAME PORTABLE X-RAY UNIT, IT KEPT EXPOSING RATHER THAN TERMINATING THE EXPOSURE. IT IS ESTIMATED THAT THIS EXPOSURE MAY HAVE LASTED TWO TO THREE SECONDS. IT IS ASSUMED THAT THE EXPOSURE CONTINUED BECAUSE THE UNIT CONTINUED TO BEEP AT WHICH TIME THE TECH TERMINATED THE EXPOSURE. THE UNIT WAS SECURED AND A RADIATION PHYSICIST AS WELL AS GENERAL ELECTRIC WAS CALLED TO EXAMINE THE UNIT. THE PHYSICIST TESTED THE UNIT WITHIN HOURS OF THE EXPOSURE. SHE WAS UNABLE TO DUPLICATE THE PROBLEM. HOWEVER, SHE DID NOTE IN HER TESTING OF THE UNIT THAT IT APPEARED TO SHUT OFF PREMATURELY; HENCE THE PROBABLE PROBLEM WITH THE FIRST FILM BEING TOO LIGHT. WHEN THE TECH READJUSTED THE FACTORS, IT IS POSSIBLE THAT IT THEN STAYED ON TOO LONG. THE PHYSICIST DOES NOT CONSIDER THIS A USER ERROR, BUT RATHER AND EQUIPMENT PROBLEM. ON DECEMBER 24, 1996, GENERAL ELECTRIC ALSO TESTED THE UNIT. THEY WERE UNABLE TO DUPLICATE THE PROBLEM AS WELL AND COMPLETED AN EXAMINATION OF THE UNIT. THEY PERFORMED SOME TEST EXPOSURES AND FOUND NO PROBLEMS WITH THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC PORTABLE X-RAY UNIT AMX 3 PORTABLE X-RAY UNIT IZL GENERAL ELECTRIC CO 46-184857G1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR