BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO

    MDR report key: 17780598 · Received September 20, 2023

    Report

    Report Number
    17780598
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    July 14, 2023
    Report Date
    July 17, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AIRVO TUBING BECAME DISCONNECTED FROM DEVICE, CAUSING PATIENT'S OXYGEN LEVELS TO DROP TO 50%, AND PATIENT BECAME DIZZY AND SHORT OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614443 AIRVO HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV FISHER & PAYKEL HEALTHCARE LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown