BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOTEC

    MDR report key: 601713 · Received May 5, 2005

    Report

    Report Number
    601713
    Event Type
    Death
    Date Received
    May 5, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 5, 2005
    Manufacturer
    FLOTECH
    Product Code
    CAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENT DEPENDENT PT PRESENTED TO MRI FOR A SERIES OF ORDERED TESTS. TRANSFERRED TO MRI BED FROM STRETCHER. PLACED ON INVIVO ECB AND PULSE OXIMETER FOR MONITORING. ALSO PLACED ON MRI COMPATIBLE OXYGEN TANK AND FLOTEC OXYGEN TANK PRESSURE GAUGE/FLOW METER. THE FLOTEC GAUGE/METER WAS NEW TO THE MRI DEPT. SINCE IT WAS NEW MRI TECHS THOUGHT IT READ DIFFERENTLY - GREY WINDOW MEANT OXYGEN FLOWING TO PT WOULD GO TO RED AREA WHEN TANK EMPTY. PT WAS HANDBAGGED AT 15 LITERS OF OXYGEN FLOW FOR PROCEDURE. UPON CHANGING OXYGEN TANKS, PRIOR TO STARTING MRI, RESPIRATORY THERAPIST QUESTIONED GAUGE, MRI STAFF EXPLAINED IT WAS A NEW GAUGE AND ALL STAFF COULD HEAR AND FEEL FLOW SO IT WAS DECIDED TO GO AHEAD WITH USING THAT TANK/GAUGE AS O2 SATS AND HEART RATE APPEARED FINE ON MONITOR. APPROX 45 MINS INTO MRI PT BEGAN HICCUPING. NURSE CALLED FOR THE FLOOR TO BRING ATIVAN TO HELP CALM PT AND DECREASE MOVEMENT. WHEN RN FROM FLOOR ARRIVED 8 MINS LATER, NOTED PT TO BE MOTTLED, UNRESPONSIVE AND WITHOUT HEARTRATE, ECG READING IN 70'S AND WITH A PULSE READING OF 95-97. PT WAS A DNR, NO FURTHER MEASURES TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC E CYLINDER REGULATOR CAN FLOTECH DR803-710 MI 710 MI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death