BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3962778 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05316
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 20, 2014
    Manufacturer
    GE EOC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REAL TIME OPERATING SYSTEM (RTOS) AND THE INTERCONNECT CABLE 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 THE SYSTEM DISPLAY A COMMUNICATION ERROR AND LOCKED UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364628 9900 FLUOROSCOPIC X-RAY JAA GE EOC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1