BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3772133 · Received January 2, 2014

    Report

    Report Number
    1720753-2014-00028
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM SOFTWARE AND CALIBRATIONS FOR THE GIB AND FFB PCB WERE EVALUATED AND RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1