BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC FLUOROSTAR 7800

    MDR report key: 1152385 · Received September 10, 2008

    Report

    Report Number
    9680959-2008-00095
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS ADJUSTED 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

    IT WAS REPORTED THAT THE COLLIMATOR ON THE FLUOROSTAR 7800 SYSTEM WAS OPEN TOO LARGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC FLUOROSTAR 7800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1