BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 917065 · Received September 21, 2007

    Report

    Report Number
    1720753-2007-05951
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 21, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. RELOADED SYSTEM SOFTWARE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM WAS UNABLE TO RECALL AND COPY CERTAIN IMAGES TO THE DVD BURNER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR