BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1070799 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22839
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP T'SHOOTING, CHECKED FUSES, CONNECTORS/ INTERCONNECT CABLE. RE-SEATED BOARDS. RE-LOAD SOFTWARE/ CAL. FILES ADJUSTED SHARPNESS DEFAULT SETTINGS, SYSTEM OPERATING NORMALLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SYSTEM ERROR" DISPLAYED ON RIGHT MONITOR, "X-RAYS DISABLED" DISPLAYED ON LEFT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1