BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3101455 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05567
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE JOYSTICK WAS IDENTIFIED AS REQUIRING REPLACEMENT. A LOANER JOYSTICK WAS GIVEN TO THE CUSTOMER UNTIL A REPLACEMENT COULD BE ORDERED. NO FURTHER REPAIR INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RUI (REMOTE USER INTERFACE/ JOYSTICK) WAS NOT WORKING. THIS IS CRITICAL FOR THE TYPE OF THE IMAGING THE MOTORIZED C-ARM WAS DESIGNED FOR. THE SYSTEM WOULD BE EFFECTIVELY UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193161 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1