BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESTIVA/5 MRI

    MDR report key: 818923 · Received January 27, 2006

    Report

    Report Number
    818923
    Event Type
    Death
    Date Received
    January 27, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 27, 2006
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE MRI SUITE RECEIVING AN MRI OF THE HEAD AND WAS BEING VENTILATED BY A MRI COMPATIBLE VENTILATOR. AFTER THE PATIENT HAD BEEN IN THE MRI ROOM FOR APPROXIMATELY 24 MINS, THE STAFF ENTERED THE MRI ROOM TO ADMINISTER MEDICATION TO THE PATIENT, THE VENTILATOR ALARM SOUNDED AND THE STAFF OBSERVED THE SCREEN DISPLAYING THE VENTILATOR SETTINGS GO BLACK AND THEN COME BACK ON AND ALARMING. THE SCREEN READ "SUSTAINED MAXIMUM." PATIENT WAS IMMEDIATELY REMOVED FROM THE VENTILATOR AND AN AMBU BAG WAS APPLIED TO THE ET TUBE WITH 100% 02. PATIENT SUBSEQUENTLY DEVELOPED PULSELESSNESS AND CPR WAS STARTED. PATIENT WAS SHOCKED DURING THE CODE AND COMPRESSIONS WERE CONTINUED FOR ABOUT 30 MINUTES. AFTER PATIENT WAS SHOCKED, PULSE WAS REGAINED. AFTER PATIENT WAS RETURNED TO HER ROOM AND THE CODE HAD ENDED, A CXR WAS TAKEN WHICH REVEALED BILATERAL PNEUMOTHORAX WHICH WAS RESOLVED WITH CHEST TUBES. THE PATIENT CONTINUED TO DETERIORATE AND DIED LATER IN THE EVENING. ALTHOUGH IT APPEARS THE MACHINE MALFUNCTIONED, WE ARE UNSURE IF THIS MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH DUE TO THE PATIENT SUFFERING FROM SEVERAL COMORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA/5 MRI ANESTHESIA DELIVERY SYSTEM LNH DATEX-OHMEDA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| L| R