BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC FLUOROSTAR 7700

    MDR report key: 1152386 · Received September 10, 2008

    Report

    Report Number
    9680959-2008-00096
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 FLUOROSTAR 7700 SYSTEM HAD A NO STATOR ERROR MESSAGE AT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC FLUOROSTAR 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1