BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2935235 · Received January 28, 2013

    Report

    Report Number
    1720753-2013-01126
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    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 ONSITE INVESTIGATION. THE RUI CONSOLE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A "JOYSTICK FAILURE ERROR" MESSAGE AND THE JOYSTICK WAS UNRESPONSIVE. THE JOYSTICK IS CRITICAL FOR THE TYPE OF IMAGING THE MOTORIZED C-ARM WAS DESIGNED FOR. AS A RESULT THE SYSTEM WOULD BE EFFECTIVELY UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38109 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1