BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATEX OHMEDA, INC

    MDR report key: 385476 · Received March 27, 2002

    Report

    Report Number
    385476
    Event Type
    Death
    Date Received
    March 27, 2002
    Date of Event
    March 7, 2002
    Report Date
    March 20, 2002
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PUT UNDER ANESTHESIA AND INTUBATED. THE CRNA EXPERIENCED DIFFICULTY VENTILATING THE PT. THE PT WAS REINTUBATED, AND PT WAS GIVEN BRONCHODILATORS TO ADDRESS POTENTIAL BRONCHOSPASM. IT WAS FELT THAT OXYGEN WAS BEING DELIVERED TO THE PT, BUT THERE WAS A PROBLEM WITH EXHALATION. THE CRNA QUESTIONED WHETHER THE EXHALATION VALVE WAS WORKING PROPERLY. OXYGEN SATURATION LEVELS REMAINED WITHIN NORMAL LIMITS. WITHIN SEVERAL MINUTES AFTER INTUBATION THE PT WENT INTO V-TACH AND A CODE WAS CALLED. RESUSCITATION EFFORTS TOOK APPROX 25 TO 35 MINUTES AND EVENTUALLY SINUS TACHYCARDIA WAS ESTABLISHED. PT WAS TRANSFERRED TO ICU AND TREATED FOR SUSPECTED PULMONARY EMBOLISM. PT ARRESTED AND DIED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX OHMEDA, INC VENTILATOR CBK DATEX-OHMEDA, INC 7000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death