BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3832673 · Received March 27, 2014

    Report

    Report Number
    9680959-2014-00416
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS INTERMITTENTLY UNABLE TO PERFORM FLUOROSCOPY. UPON REBOOT, SYSTEM FUNCTIONALITY WAS RECOVERED. 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
    179391 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1