BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1071186 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22964
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 27, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CANDLESTICKS WERE CLEANED AND RE-GREASED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM INTERMITTENTLY HAD GRAINY AND BLACK IMAGES. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1