BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2191221 · Received July 19, 2011

    Report

    Report Number
    1720753-2011-20188
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. ASSISTANCE WAS PROVIDED TO ADJUST AND ALIGN THE NEW COLLIMATOR AND TESTING OF THE DOSE SETTINGS AND DOSE AREA PRODUCT. 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

    THE CUSTOMER REPORTED THAT THERE WERE COLLIMATOR POTENTIOMETER ERRORS ON BOOT UP. THE PHYSICS REPORT SHOWED THE DOSE VALUES WERE INCORRECT AND THE SYSTEM'S DOSE AREA PRODUCT NEEDED ADJUSTING AND THAT THE IMAGES SECTOR DOSAGES NEEDED TO BE CONFIRMED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1