BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 19827018 · Received July 25, 2024

    Report

    Report Number
    19827018
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 22, 2024
    Manufacturer
    VYAIRE MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS STATUS POST RESPIRATORY ARREST. PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR DURING RESPIRATORY ARREST. PATIENT WAS TO TRANSFER TO THE ICU. DURING TRANSPORT TO THE ICU, THE VYAIRE MEDICAL LTV VENTILATOR SHUT OFF FOR A FEW SECONDS THEN CAME BACK ON. NO HARM TO PATIENT AND THE SHUT DOWN WAS ONLY A FEW SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365375 LTV VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC. 18888-001 E84504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown