BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1071141 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22932
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REO ADJUSTED IMAGING AND MONITOR DEFAULTS IN RUS. TESTED IMAGES APPEAR TO BE IMPROVED. INSTRUCTED CUSTOMER TO CONTACT GE IF FURTHER ADJUSTMENTS ARE NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY WERE GETTING "WASHED OUT" IMAGES WHEN USING AUTO TECHNIQUE AND CONTRAST. SHE REPORTS THAT SHE MUST MANUALLY MANIPULATE IMAGE TO GET IT TO LOOK PROPER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1