BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 6630442 · Received June 2, 2017

    Report

    Report Number
    6630442
    Event Type
    Death
    Date Received
    June 2, 2017
    Date of Event
    April 27, 2017
    Report Date
    May 31, 2017
    Manufacturer
    CAREFUSION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CODE PT WAS INTUBATED AND VENTILATIONS WERE ATTEMPTED WITH THE PRODUCT FOUND TO BE DEFECTIVE. THERE WAS NO EVIDENCE OF VENTILATION. PT WAS REINTUBATED THRICE - THE THIRD TIME WITH GLIDESCOPE STILL NOT EVIDENCE OF VENTILATION. FURTHER TROUBLE SHOOTING LED TO EXCHANGE OF AMBUBAG AND THEN SUCCESS OF VENTILATION. REF MW5069564, REF #8030673-2017-00338.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390346 CAREFUSION AMBU BAG BTM CAREFUSION 2K8005 0001040664

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death