BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2101797 · Received May 10, 2011

    Report

    Report Number
    1720753-2011-07151
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED, THE FILAMENTS WERE CALIBRATED AND THE INTERCONNECT CABLE AND HIGH VOLTAGE CABLE ASSEMBLY WERE INSPECTED. 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 WOULD CONTINUE TO APPEAR AS IF IT WAS PERFORMING FLUOROSCOPY EVEN AFTER THE SWITCH WAS RELEASED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1