BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1040779 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21347
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM MADE LOUD NOISE FROM THE X-RAY TUBE. ALSO, HAD POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1