BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1083650 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-23967
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PERFORMED A COLLIMATOR CALIBRATION. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM IS DISPLAYING INTERMITTENT "IRIS TOO LARGE" ERRORS. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1