BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2043580 · Received March 28, 2011

    Report

    Report Number
    9680959-2011-00891
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PC GUARD AND FRAME GRABBER WERE RECONNECTED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CAMERA ERRORS ON THE 7900 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1