BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1852055 · Received September 28, 2010

    Report

    Report Number
    1720753-2010-03248
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CABLE WAS REPAIRED AND THE IMAGE PROCESSOR, VIDEO CONTROLLER, AND DISPLAY ADAPTOR WERE REPLACED 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 HAD POOR IMAGE QUALITY WITH TOO DARK IMAGES AND A LINE IN THE MIDDLE OF THE IMAGE. NO PATIENT 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