BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1191425 · Received October 9, 2008

    Report

    Report Number
    1720453-2008-25306
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 2, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS ADJUSTED AND CALIBRATED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM HAD A COLLIMATOR IRIS POTENTIOMETER ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1