BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2191531 · Received July 27, 2011

    Report

    Report Number
    1720753-2011-20482
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE X-RAY BEAM WAS ADJUSTED BACK INTO TOLERANCE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    DURING ROUTINE MAINTENANCE THE X-RAY BEAM WAS FOUND TO BE OUT OF TOLERANCE. 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