BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3960135 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05361
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR AND FILAMENT WAS CALIBRATED AND THE HAND SWITCH WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND SWITCH LOCKED UP WHILE MAKING AN EXPOSURE AND THE SYSTEM CONTINUED TO X-RAY DURING A PROCEDURE WITH A PT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367527 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1