BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2781356 · Received October 10, 2012

    Report

    Report Number
    1720753-2012-08163
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 10, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RE-LUBRICATED THE BEARINGS AND STEERING CHAIN. THE SYSTEM OPERATES AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STEERING HANDLE THAT CONTROLS LATERAL MOVEMENT WAS STIFF AND DIFFICULT TO MANIPULATE. THERE WAS NO REPORT OF A PATIENT DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1