BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1232502 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-28087
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM HAD ARCING WITH POOR IMAGE QUALITY. ALSO THERE WAS A LOW MA ERROR MESSAGE DISPLAYED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1