BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1359635 · Received March 3, 2009

    Report

    Report Number
    1720753-2009-01788
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP TESTED THE UNIT FOR LINE PAIR RESOLUTION. THE UNIT WAS WITHIN SPECIFICATIONS. HE TESTED THE AUTO TRACKING AND FOUND THE TRACKING TO BE RUNNING ABOUT 1KV HIGH. THIS CAN DEFINITELY CAUSE IMAGES TO APPEAR WASHED OUT. THE REP ADJUSTED THE TRACKING WITH THE CAMERA IRIS STOP ADJUSTMENT AND TRACKING IS NOW WITHIN SPECIFICATIONS. WHEN THE CAMERA COVER WAS REMOVED, HE FOUND THE CABLE SECURING A SCREW FLOATING AROUND THE CAMERA BOARDS. HE REATTACHED THE SCREW, IT IS POSSIBLE THIS SCREW COULD HAVE TOUCHED A BOARD AND CAUSED SOME IMAGING ISSUES. HE FOUND THE COLLIMATOR WAS OUT OF ALIGNMENT THEN ADJUSTED THE COLLIMATOR FOR NORMAL BEAM ALIGNMENT. ON LOW FLUORO SHOTS MA ERROR DISPLAYED. THE REP TESTED THE MA NULL ON HVSR BOARD READING NORMAL THEN PERFORMED A FILAMENT CALIBRATION AND TESTED LOW FLUORO. THE UNIT WAS WORKING NORMALLY AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POOR IMAGE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1