BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4180562 · Received October 15, 2014

    Report

    Report Number
    1720753-2014-08633
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 15, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. 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 THE CUSTOMER WAS UNABLE TO SAVE OR REVIEW IMAGES THAT HAD BEEN SAVED WITHIN CINE. THE CINE FUNCTION FAILED TO OPERATE, THEREBY LOSING SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656265 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1