BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800/9900 ELITE

    MDR report key: 781451 · Received November 10, 2006

    Report

    Report Number
    1720753-2006-00144
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    October 15, 2006
    Report Date
    November 10, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAVIGATION ACCURACY OF THE A/P (ANTERIOR/POSTERIOR) AND THE LATERAL POSITION OF THE C-ARM IS NOT EQUIVALENT ON THE 9800/9900 ELITE SYSTEM. THE RESULTING ACCURACY OF THE BBN FAF TEST EXCEEDS 3.0 MM, WHICH CONSTITUES A FAILURE TO THE PRODUCT SPECIFICATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800/9900 ELITE FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *