BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3801848 · Received February 11, 2014

    Report

    Report Number
    1720753-2014-01362
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO DISPLAY FLUOROSCOPIC EXPOSURE AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90019 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1