BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY

    MDR report key: 2445633 · Received February 2, 2012

    Report

    Report Number
    2445633
    Event Type
    Death
    Date Received
    February 2, 2012
    Date of Event
    January 19, 2012
    Report Date
    February 2, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MONITOR WAS TAKEN OFF THE DOCKING STATION IN ICU FOR TRANSPORT OF THE PATIENT FOR A CT. THE PATIENT WAS TRANSPORTED TO THE CT ON THE MONITOR. THE PATIENT WAS PLACED IN THE CT MACHINE AND THE CT WAS STARTED. ALL STAFF EXITED THE CT ROOM AND CLOSED DOOR. AFTER COMPLETION OF CT THE STAFF RE-ENTERED THE ROOM AND IMMEDIATELY NOTICED THAT MONITOR WAS OFF. THIS WAS 25 MINUTES FROM THE TIME THE TRANSPORT STARTED. THE PRIMARY CARE TEAM (PCT) BEGAN ATTEMPTING TO TURN THE MONITOR BACK ON AND THE PATIENT WAS TAKEN OUT OF THE CT MACHINE AND MOVED BACK TO BED. THE PATIENT BECAME BLUE AND BEGAN AGONALLY BREATHING. WE WERE UNABLE TO TURN MONITOR BACK ON. THE CT STAFF WENT TO FIND THE PORTABLE CHARGER. THE PATIENT BECAME GREY AND THE RN RETRIEVED A CRASH CART TO MONITOR THE PATIENT. WHEN PLACED ON CRASH CART MONITOR THE PATIENT WAS IN ASYSTOLE. EPINEPHRINE WAS GIVEN, CPR STARTED, AND CODE BLUE CALLED. PATIENT DID NOT SURVIVE CODE AND TIME OF DEATH WAS 42 MINUTES FROM THE TIME THE MONITOR WAS FOUND POWERED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY MONITOR, PHYSIOLOGICAL DSI DRAEGER MEDICAL SYSTEMS, INC. SC 7000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death