BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2031304 · Received March 16, 2011

    Report

    Report Number
    1720753-2011-02404
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    July 21, 2009
    Report Date
    March 16, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE MILLIAMPS LIMIT WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9800 SYSTEM IN NORMAL LEVEL FLUORO EXCEEDS THE STATE LIMIT OF 5 R/MINUTE. 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 INC. 9800

    Patients

    Seq Age Sex Outcome Treatment
    1