BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 788663 · Received November 20, 2006

    Report

    Report Number
    1720753-2006-00184
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Date of Event
    October 24, 2006
    Report Date
    November 20, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER WOULD NOT ALLOW THE SERVICE REPRESENTATIVE TO ADJUST THE HFL FLUORO DOSE RATE DOWN BECAUSE THIS WOULD AFFECT THE IMAGE QUALITY. THE AUTO HFL FLUORO DOSE IS WITHIN THE LIMIT OF 100MGY AND THE SYSTEM IS ONLY USED IN AUTO MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM EXCEEDS THE MAXIMUM MANUAL HLP FLUORO DOSE OUTPUT SET BY THE COUNTRY'S EPA AT 50MGY. NO PT 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 *