BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3971117 · Received April 29, 2014

    Report

    Report Number
    1720753-2014-03742
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 29, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM INTERFACE BOARD AND THE X-RAY CONTROLLER WERE REPLACED DURING THE SERVICE CALL. 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 DISPLAYED AN X-RAY DISABLED ERROR MESSAGE. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256295 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1