BEUDAMED
    FDA Adverse Event Death Summary report: N

    KING AIRWAY

    MDR report key: 1010543 · Received March 11, 2008

    Report

    Report Number
    1010543
    Event Type
    Death
    Date Received
    March 11, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 4, 2008
    Manufacturer
    KING SYSTEMS
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS A WITNESSED ARREST. WHEN EMT'S CAME TO ASSIST THEY USED A KING AIRWAY TO STABILIZE AIRWAY. O2 SATS 100% ON ARRIVAL TO ER. HOWEVER, PT HAD TO HAVE AN EMERGENCY TRACHEOTOMY AS UNABLE TO PLACE ET TUBE. AFTER SWELLING HAD GONE DOWN, IT WAS DETERMINED TRACHEA WAS PERFORATED. CANNOT RULE OUT DEVICE ROLE IN EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KING AIRWAY AIRWAY MANAGEMENT CAE KING SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death