BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 892949 · Received May 25, 2007

    Report

    Report Number
    892949
    Event Type
    Death
    Date Received
    May 25, 2007
    Date of Event
    April 20, 2007
    Report Date
    May 21, 2007
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    TOWARDS THE END OF THE COLONOSCOPY PATIENT VOMITED FECAL LOOKING VOMIT. PATIENT ALREADY LATERALLY POSITIONED FOR PROCEDURE, ORALLY SUCTIONED WITH YANKER AND SUCTIONED VIA PEG TUBE. OXYGEN SATURATIONS BEGAN TO DECREASE. OXYGEN SATURATIONS WERE DIFFICULT TO ASSESS WITH FINGER PROBE AND EAR PROBE. PHYSICIAN WAS CALLED TO BEDSIDE. ARTERIAL BLOOD GASES DRAWN. PATIENT WITH LABORED BREATHING THEN LOSS OF CONSCIOUSNESS. PATIENT INTUBATED AND CPR STARTED. FAILURE TO RESUSCITATE AFTER APPROXIMATELY 30 MINUTES. EQUIPMENT HAS BEEN SENT FOR MAINTENANCE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ENDOSCOPE KOG OLYMPUS AMERICA, INC. CF-140L *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death