BEUDAMED
    FDA Adverse Event Death Summary report: N

    KING AIRWAY LTD

    MDR report key: 6056860 · Received October 24, 2016

    Report

    Report Number
    MW5065599
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 24, 2016
    Manufacturer
    KING SYSTEMS
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING AIRWAY MANAGEMENT OF A PT IN RESPIRATORY FAILURE, KING AIRWAY WAS PLACED. SHORTLY THEREAFTER, AFTER PLACEMENT OF THE AIRWAY DEVICE AND INFLATION OF THE CUFF, AIR BEGAN TO LEAK FROM CUFF. TWO ATTEMPTS MADE TO RE-INFLATE THE CUFF TO MFR'S RECOMMENDATIONS, BUT THE CUFF BEGAN TO LEAK AFTER 4-5 VENTILATIONS. DEVICE WAS PULLED AND MANUAL MANAGEMENT OF VENTILATIONS PERFORMED WITH A BAG-VALVE MASK. EVENTUALLY, A SECOND KING AIRWAY PLACED SUCCESSFULLY. UNFORTUNATELY, ALL PACKAGING WITH CORRESPONDING LOT NUMBER ETC., WAS DISCARDED AT THE EMERGENCY SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701631 KING AIRWAY LTD AIRWAY CAE KING SYSTEMS KLTD214

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death