BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9400

    MDR report key: 1030877 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20588
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BOOST DOSE RATE WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOOST DOSE RATE ON THE 9400 SYSTEM WAS TOO HIGH. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9400 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1