BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2223088 · Received August 10, 2011

    Report

    Report Number
    1720753-2011-20890
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 10, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE LOWERED THE MAXIMUM BOOST PERCENTAGE AND PERFORMED A BEAM ALIGNMENT IN ALL THREE MAGNIFICATION MODES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD PRODUCE A HIGH SKIN DOSE LEVEL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1