BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE OEC 9600

    MDR report key: 1161785 · Received September 12, 2008

    Report

    Report Number
    1720753-2008-25700
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE REPORTED CONCERN WITH IMAGE QUALITY AND FOUND THAT THE USER HAD DISABLED THE AUTO-HISTOGRAM FUNCTION FOR THE IMAGES WITH QUESTIONABLE IMAGE QUALITY. THERE WAS NO SYSTEM MALFUNCTION OR SERVICE ISSUES WITH THE SYSTEM. THE SYSTEM WAS FUNCTIONING AS INTENDED AND THE USER WAS ADVISED TO KEEP THE AUTO-HISTOGRAM FUNCTION 'ON' DURING PROCEDURES TO ALLOW AUTOMATIC ADJUSTMENT OF THE BRIGHTNESS AND CONTRAST FUNCTIONS AND TO FURTHER SELECT THE ORTHOPEDIC PROFILE IF THE GENERAL FLUORO PROFILE IS NOT ADEQUATE FOR IMAGE QUALITY FOR ORTHOPEDIC CASES. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. A FOLLOW-UP ON THE PATIENT CONDITION REVEALED THAT THE PROCEDURE TIME WAS PROLONGED A SHORT AMOUNT OF TIME. HOWEVER, THERE WAS NO RESULTING NEGATIVE EFFECT TO PATIENT CONDITION OR RECOVERY NOTED.

    Description of Event or Problem · 1

    THE GE OEC 9600 FLUOROSCOPY SYSTEM WAS REPORTED TO HAVE PROLONGED AN ORTHOPAEDIC SURGERY CASE DUE TO POOR IMAGE QUALITY.

    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 Other