BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1040778 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21346
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE WAS CLEARED AND THE SOFTWARE WAS RE-INSTALLED 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 9800 SYSTEM INTERMITTENTLY WOULD NOT FLUORO. THE HARD DRIVE WAS SLOW AND THERE WERE IMAGES MISSING. 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