BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 3874550 · Received April 22, 2014

    Report

    Report Number
    9680959-2014-00566
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 22, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE MONITOR WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE USERS COULD NOT SEE THE LIVE FLUOROSCOPIC IMAGES. THIS CAN RESULT IN THE SYSTEM BEING UNUSABLE DUE TO THE INABILITY TO DISPLAY THE LIVE FLUOROSCOPIC IMAGE. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243737 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1