BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800 12 STD C ARM SP GSP ESP

    MDR report key: 1645709 · Received March 12, 2010

    Report

    Report Number
    1720753-2010-00689
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    December 31, 2009
    Report Date
    March 10, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HIGH VOLTAGE TANK. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM IS DISPLAYING FILAMENT AND OVERLOAD ERRORS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 12 STD C ARM SP GSP ESP C-ARM JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1