BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 2954124 · Received July 12, 2007

    Report

    Report Number
    1720753-2007-08893
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 12, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. INVESTIGATION IDENTIFIED CONTROL PANEL ERRORS. REPLACED CONTROL PANEL PROCESSOR AND SUBSEQUENTLY THE FLUORO FUNCTION BOARD. CHECKED SYSTEM AND SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM 9800 WOULD INTERMITTENTLY STOP DURING CASE. PT INFO NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK