BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3882829 · Received April 10, 2014

    Report

    Report Number
    9680959-2014-00491
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS CALIBRATED 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 THAT THE SYSTEM FAILED TO DISPLAY A FLUOROSCOPIC IMAGE. FURTHER INVESTIGATION BY THE FSE FOUND THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216605 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1