BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYAIRE MEDICAL, INC. VYAIRE LTV VENTILATOR

    MDR report key: 10453486 · Received August 25, 2020

    Report

    Report Number
    MW5096253
    Event Type
    Death
    Date Received
    August 25, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 21, 2020
    Manufacturer
    VYAIRE MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    I AM WRITING TO INFORM YOU OF AN ADVERSE EVENT THAT WAS REPORTED ON (B)(6) 2020 INVOLVING A LTV VENTILATOR THAT WAS USED BY ONE OF OUR PATIENTS AT HOME. THE SPOUSE REPORTED THE ALARMS DID NOT ACTIVATE WHEN THE TUBING DETACHED FROM THE TRACHEA, RESULTING IN PATIENT DEATH. THE SERIAL NUMBERS ARE (B)(4). VYAIRE MEDICAL HAS BEEN NOTIFIED AND HAS THE EQUIPMENT. VYAIRE (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911096 VYAIRE MEDICAL, INC. VYAIRE LTV VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC.
    911097 VYAIRE LTV VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death