BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 876350 · Received July 9, 2007

    Report

    Report Number
    1720753-2007-03079
    Event Type
    Malfunction
    Date Received
    July 9, 2007
    Date of Event
    June 15, 2007
    Report Date
    July 11, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE PROCESSOR AND DISPLAY ADAPTER PCB ALONG WITH THE SBC. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 WOULD INTERMITTENTLY NOT FULLY BOOT AND WOULD STOP AT 5 ARROWS. NO PT. INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR