BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800MD

    MDR report key: 930265 · Received October 22, 2007

    Report

    Report Number
    1720753-2007-06811
    Event Type
    Malfunction
    Date Received
    October 22, 2007
    Date of Event
    September 28, 2007
    Report Date
    October 22, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN EVALUATION OVER THE TELEPHONE. THE MALFUNCTION WAS VERIFIED. THE JOYSTICK WILL BE REPLACED ONCE FUNDING IS MADE AVAILABLE. NO FURTHER PROBLEMS ARE ANTICIPATED FOLLOWING REPLACEMENT. AN ADDITIONAL REPORT WILL BE GENERATED AND SUBMITTED IF FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOYSTICK OF THE OMD WAS INTERMITTENTLY FAILING CAUSING A GROSS LOSS OF C ARM MOVEMENT FUNCTIONALITY. THERE WAS NO ADVERSE PATIENT INVOLVEMENT REPORTED. THERE WAS NO PATIENT INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR