BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1791392 · Received August 6, 2010

    Report

    Report Number
    9680959-2010-00255
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    May 17, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 7700 SYSTEM HAD INTERMITTENT LOSS OF IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1