BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESTIVA/5 MRI

    MDR report key: 676338 · Received January 30, 2006

    Report

    Report Number
    MW1037895
    Event Type
    Death
    Date Received
    January 30, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 30, 2006
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN THE MRI SUITE RECEIVING AN MRI OF THE HEAD AND WAS BEING VENTILATED BY A MRI COMPATIBLE VENTILATOR. AFTER THE PT HAD BEEN IN THE MRI ROOM APPROX 24 MINS THE STAFF ENTERED THE MRI ROOM TO ADMINISTER MEDS TO THE PT, THE VENTILATOR ALARM SOUNDED AND THE STAFF OBSERVED THE SCREEN DISPLAYING THE VENTILATOR SETTINGS GO BLACK AND THEN COME BACK AND ON ALARMING. THE SCREEN READ "SUSTAINED MAXIMUM". PT WAS IMMEDIATELY REMOVED FROM THE VENTILATOR AND AN AMBU BAG WAS APPLIED TO THE ET TUBE WITH 100% O2. PT SUBSEQUENTLY DEVELOPED PULSELESSNESS AND CPR WAS STARTED. PT WAS SHOCKED DURING THE CODE AND COMPRESSIONS CONTINUED FOR ABOUT 3O MINS. AFTER PT WAS SHOCKED PULSE WAS REGAINED. AFTER PT 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 PT CONTINUED TO DETERIORATE AND DIED LATER IN THE EVENING. ALTHOUGH IT APPEARS THE MACHINE MALFUNCTIONED, RPTR IS UNSURE IF THIS MALFUNCTION CONTRIBUTED TO THE PT'S DEATH DUE TO THE PT SUFFERING FROM MULTIPLE COMORBIDITIES.

    Devices

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

    Patients

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