BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4180959 · Received October 10, 2014

    Report

    Report Number
    1720753-2014-08519
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS EVALUATED, REPLACED AND RECALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD AN OVERRIDE FAULT ERROR. THE FSE EXPLAINED THAT THE SYSTEM WAS UNABLE TO DO X-RAY WHICH CAN CAUSE THE SYSTEM TO BECOME UNUSABLE; DUE TO INABILITY TO PRODUCE A LIVE IMAGE. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643150 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1