BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2031260 · Received March 16, 2011

    Report

    Report Number
    1720753-2011-02367
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OIL WAS LEAKING FROM THE X-RAY TUBE ON THE 9600 SYSTEM. NO PT 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