BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2941346 · Received January 31, 2013

    Report

    Report Number
    1720753-2013-01343
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 31, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS CALIBRATED 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 SYSTEM HAD A COLLIMATOR IRIS POTENTIOMETER ERROR DURING A PROCEDURE WITH A PT INVOLVE; THEREFORE, THIS MALFUNCTION MYA HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43526 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1