BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4142894 · Received September 12, 2014

    Report

    Report Number
    1720753-2014-07866
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CINE FUNCTION WAS NOT OPERATING CORRECTLY. THIS RESULTED IN LOSS OF SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. 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
    565262 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1