BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM PRECISION FLOW HI-VNI

    MDR report key: 23568595 · Received November 17, 2025

    Report

    Report Number
    MW5178931
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 12, 2025
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, WHILE IN USE ON A PATIENT THE VAPOTHERM HEATED HIGH FLOW NASAL CANNULA DEVICE MALFUNCTIONED. DEVICE WAS ON THE PATIENT AND STOPPED FUNCTIONING. THE WAS NO FLOW OR FIO2 READINGS AND THERE WAS A GENERAL FAULT ALARM INDICATOR WITH AN UNKNOWN NUMBER IN THE TEMPERATURE WINDOW. THE NURSE WAS PRESENT IN THE ROOM WHEN THE DEVICE MALFUNCTIONED. PATIENT WAS PLACED ON NON-REBREATHER MASK, RT WAS NOTIFIED AND A NEW HEATED HIGH FLOW DEVICE WAS PLACED ON THE PATIENT. THE PATIENT TOLERATED THE CHANGE OVER WELL WITH NO HARM. THE UNIT WAS TAKEN OUT OF SERVICE AND SENT TO BIOMED FOR EVALUATION. VAPOTHERM PRECISION FLOW HI-VNI DEVICE, SERIAL NUMBER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872910 VAPOTHERM PRECISION FLOW HI-VNI HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other