BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900 ELITE

    MDR report key: 2971439 · Received October 8, 2007

    Report

    Report Number
    1720753-2007-06268
    Event Type
    Malfunction
    Date Received
    October 8, 2007
    Date of Event
    September 13, 2007
    Report Date
    October 1, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP INVESTIGATED THE ISSUE AND PERFORMED A CAMERA ALIGNMENT AND IMAGE INTENSIFIER FOCUS ADJUSTMENT. SYSTEM RETURNED TO SPECIFICATIONS. THE SYSTEM HAD BEEN TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.

    Description of Event or Problem · 1

    THE GE OEC 9900 FLUOROSCOPY SYSTEM HAD POOR IMAGE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 ELITE FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1