BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2782032 · Received October 5, 2012

    Report

    Report Number
    1720753-2012-08050
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 5, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS RE-GREASED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THE SERVICE REPRESENTATIVE RECOMMENDED TO THE CUSTOMER THAT THE X-RAY TUBE BE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN WITHOUT COMMAND. THERE IS NO REPORT OF PT 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