BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1021680 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19680
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND ADJUSTED THE MA LIMITS TO BRING THE SYSTEM INTO COMPLIANCE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM OUTPUT DOSE EXCEEDED THE NEVADA LIMIT OF 5R/MIN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1