BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSTAR

    MDR report key: 1800058 · Received August 11, 2010

    Report

    Report Number
    9680959-2010-00267
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE COLLIMATOR WAS REPLACED AND 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 7900 SYSTEM HAD A COLLIMATOR IRIS POTENTIOMETER ERROR MESSAGE 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