BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OCE 9800

    MDR report key: 1587100 · Received January 14, 2010

    Report

    Report Number
    1720753-2010-00101
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 13, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED AND THE FILAMENT WAS CALIBRATED 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 BLACK IMAGES ON THE LEFT MONITOR PRIOR TO A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OCE 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1