BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE 7700 FLUOROSTAR

    MDR report key: 1052369 · Received April 30, 2008

    Report

    Report Number
    9680959-2008-00070
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR AND THE TUBE WERE 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

    IT WAS REPORTED THAT THE 7700 SYSTEM HAD POOR IMAGE QUALITY DURING A CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE 7700 FLUOROSTAR FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1