BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSTAR

    MDR report key: 1831934 · Received September 8, 2010

    Report

    Report Number
    9680959-2010-00319
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 12, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MONITOR CONNECTION WAS REPAIRED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 7900 SYSTEM MONITOR SHUT DOWN DURING A CASE NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1