BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3882811 · Received April 10, 2014

    Report

    Report Number
    1720753-2014-03106
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GE OEC 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 IMAGE PROCESSOR BOARD AND THE SOFTWARE WERE INSTALLED DURING THE SERVICE CALL. 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 SUBTRACTION FEATURE WAS NOT WORKING. A LOSS OF CINE, SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR FUNCTIONS COULD RESULT IN DELAY OR TERMINATION OF AN INTERVENTIONAL PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216498 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1