BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3982769 · Received July 24, 2014

    Report

    Report Number
    1720753-2014-06372
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CINE BRIDGE CONNECTIONS WERE EVALUATED AND RESEATED. THE CINE DRIVE WAS REFORMATTED. 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 CINE FUNCTION WAS NOT OPERATING CORRECTLY. A LOSS OF CINE, SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR FUNCTIONS COULD RESULT IN DELAY OR TERMINATION/RESCHEDULING OF AN INTERVENTIONAL PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435476 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1