BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE

    MDR report key: 2689192 · Received August 6, 2012

    Report

    Report Number
    2689192
    Event Type
    Injury
    Date Received
    August 6, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 6, 2012
    Manufacturer
    CAREFUSION 211, INC. BDA CAREFUSION
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED WITH RESPIRATORY FAILURE AND SEVERE HYPOXIA RELATED TO BILATERAL DENSE INFILTRATES IN LUNGS. THE SYMPTOMS DID NOT IMPROVE CLINICALLY OR RADIOGRAPHICALLY AND THE PATIENT REQUIRED INTUBATION AND THERAPEUTIC BRONCHOSCOPY. AFTER INTUBATION, THE ENDOTRACHEAL TUBE WAS CONNECTED TO THE ADULT MANUAL RESUSCITATOR BAG AND O2 SATURATION CONTINUED TO DROP DESPITE ATTEMPTS TO VENTILATE. RE-INTUBATION WAS PERFORMED WITH THE SAME DIFFICULTIES. OXYGEN FLOWMETER WAS REPLACED WITHOUT IMPROVEMENT. O2 SATURATION DROPPED EXTREMELY LOW FOR APPROX 10 MINUTES. THE ADULT MANUAL RESUSCITATOR BAG WAS REPLACED AND O2 SATURATION'S IMMEDIATELY IMPROVED. ON INSPECTION OF THE ADULT MANUAL RESUSCITATOR BAG, IT WAS DISCOVERED THAT THE OXYGEN NOZZLE ADAPTER THAT ATTACHED TO AN OXYGEN SOURCE DID NOT HAVE A PATENT OPENING. IT APPEARS SEALED WITH HARD PLASTIC. OUTCOMES ARE STILL PENDING AS PATIENT REMAINS INTUBATED AND IN CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE BAG, RESUSCITATION, MANUAL BTM CAREFUSION 211, INC. BDA CAREFUSION * 000355656

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention