BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1872057 · Received October 14, 2010

    Report

    Report Number
    1720753-2010-03564
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CAMERA, COLLIMATOR, AND FILAMENT WERE 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 A PHYSICIST DISCREPANCY OF DOSE RATE TOO HIGH. ALSO THERE WERE COLLIMATOR AND DATA ERROR MESSAGES OUTSIDE OF A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1