BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6800

    MDR report key: 1040749 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21404
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP REPLACED THE CCD CAMERA. THE IMAGE ROTATOR NOW PERFORMS AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED AN IMAGE ROTATION ERROR. THE UNIT HAD TO BE REBOOTED TO RESOLVE THE ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1