BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3821222 · Received April 16, 2014

    Report

    Report Number
    1720753-2014-03308
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER WAS ADVISED TO TURN ON THE EXTENDER CARD SWITCHES. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. THE SYSTEM WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234096 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1