BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE OEC 9800

    MDR report key: 1083456 · Received July 25, 2008

    Report

    Report Number
    1720753-2008-23998
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE REPORTED CONCERN AND COULD NOT DUPLICATE THE POOR IMAGE QUALITY AS WAS REPORTED AND FOUND NO DEVICE FAILURE OR MALFUNCTION. THE SYSTEM WAS COMPLETELY EVALUATED FOR ALL SPECIFICATIONS AND SPECIFIC ATTENTION TO IMAGE QUALITY RESOLUTION AND TECHNIQUE TRACKING. NO ISSUES WERE FOUND, AND THE SYSTEM WAS FUNCTIONING AS INTENDED. ADDITIONALLY, THE IMAGE RESOLUTION WAS FURTHER TESTED AND EVALUATED BY THE RADIATION SAFETY OFFICER AND NO IMAGE DEGRADATION WAS FOUND AND NONE FOUND SINCE THE SYSTEM'S LAST PERIODIC MAINTENANCE INTERVAL, OR THE LAST PHYSICIST'S EVALUATION ON 03/24/08. THIS SYSTEM HAD A PERIODIC MAINTENANCE CHECK BY GE HEALTHCARE SURGERY ON 05/30/08. THE SYSTEM WAS MULTI-TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY FURTHER PATIENT INFORMATION THAN NOTED.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM WAS REPORTED TO HAVE POOR IMAGE QUALITY DURING A PROCEDURE. THERE WAS A REPORTED VESSEL PERFORATION TO THE PATIENT DURING THE PROCEDURE AND THE PATIENT WAS TRANSFERRED FROM THE CARDIAC CATH LAB TO SURGERY TO REPAIR THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEM INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other