BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 10086640 · Received May 26, 2020

    Report

    Report Number
    10086640
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 20, 2020
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM PRECISION FLOW SHUT OFF, AND WAS FLASHING INDICATING THAT O2 (OXYGEN % DISPLAY) SENSOR FAILED. THE TEMPERATURE DISPLAY WAS ALSO FLASHING WITH A TEMPERATURE OF 52. STAFF UNPLUGGED THE DEVICE FROM THE POWER OUTLET, AND PLUGGED BACK IN. THE DEVICE CONTINUED DOING THE SAME THING, AND O2 SATURATIONS DECREASED THIS TIME. THE EQUIPMENT WAS REPLACED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551909 VAPOTHERM HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8395 DA