BEUDAMED
    FDA Adverse Event Death Summary report: N

    KING LTS-D KIT

    MDR report key: 10867631 · Received November 19, 2020

    Report

    Report Number
    1824226-2020-00002
    Event Type
    Death
    Date Received
    November 19, 2020
    Date of Event
    March 5, 2019
    Report Date
    November 19, 2020
    Manufacturer
    KING SYSTEMS
    Product Code
    CAE
    PMA / PMN Number
    K033186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE ONLY INFORMATION AVAILABLE IS CONTAINED WITHIN FDA'S MAUDE REPORT NUMBER (B)(4), THE END USER DID NOT FILE A COMPLAINT WITH KING SYSTEMS. IF MORE INFORMATION BECOMES AVAILABLE KING SYSTEMS WILL REVIEW IT ACCORDINGLY. KING SYSTEMS BECAME AWARE OF THIS EVENT THROUGH A REVIEW OF FDA'S MAUDE WEBSITE. KING SYSTEMS HAS NO RECORD OF RECIEVING A MEDWATCH REPORT FROM FDA FOR THIS EVENT. THIS EVENT WAS REPORTED UNDER AMBU INC. AND NOT KING SYSTEMS. WITH THE LIMITED INFORMATION AVAILABLE THROUGH THE REPORT, AND NO DEVICE AVAILABLE FOR EVALUATION, IT APPEARS THAT THE DEVICE MAY HAVE MALFUNCTIONED. KING SYSTEMS IS REPORTING THIS EVENT ALTHOUGH IT IS NOT CLEAR THAT THE POTENTIAL MALFUNCTION OF THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH.

    Description of Event or Problem · 1

    AS DESCRIBED IN MEDWATCH (B)(4): "MEDICA CREW INITIALLY ATTEMPTED INTUBATION WHICH WAS UNSUCCESSFUL, THIS WAS FOLLOWED WITH AIRWAY MANAGEMENT USING A KING LARYNGEAL TUBE. AFTER INSERTION OF THE KING AIRWAY, THE TUBE BROKE AT THE HUB WHERE THE BAG-VALVE MASK WOULD HAVE ATTACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332616 KING LTS-D KIT OROPHARYNGEAL AIRWAY CAE KING SYSTEMS KLTSD431

    Patients

    Seq Age Sex Outcome Treatment
    1 Death