BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1070278 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-20510
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECTLY RECORDED ERROR MESSAGE, NO OCCURRENCE. SYSTEM IS OPERATING AT NORMAL SETTINGS. BRIGHTNESS AND CONTRAST TO MONITORS NEED TO BE ADJUSTED. THE SERVICE REP ADJUSTED MONITOR SETTINGS TO OPTIMIZE IMAGING. VERIFIED SYSTEM SETTINGS ARE NORMAL WITH NO NOTED CHANGES IN PERFORMANCE SINCE PMI IN NOVEMBER. COMPLAINT RESTRICTED TO DARK IMAGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMAGES ARE DARK AND AN ERROR MESSAGE DISPLAYED ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1