BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1153664 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22297
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONDUCTED AN ON SITE EVALUATION. THE REPRESENTATIVE REPLACED THE FILAMENT DRIVER PCB, AND FILAMENT CALIBRATIONS WERE PERFORMED. VERIFIED SYSTEM FUNCTIONED PROPERLY. SYSTEM WAS RETURNED FOR CUSTOMER USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED FILAMENT REGULATOR ERROR DURING A CASE. 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. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1