BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1365243 · Received March 6, 2009

    Report

    Report Number
    1720753-2009-02014
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 9, 2009
    Report Date
    March 6, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND DAP TO BE OUT OF TOLERANCE BY 1.24%. GE REP PERFORMED THE DAP CALIBRATION. SYSTEM OPERATES AS INTENDED. (B) (4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DOSE AREA PRODUCT (DAP) IS OFF BY APPROXIMATELY 75%. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1