BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FLOW HI-VNI

    MDR report key: 15563058 · Received October 6, 2022

    Report

    Report Number
    MW5112497
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 5, 2022
    Manufacturer
    VAPOTHERM INC.
    Product Code
    QAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE OXYGEN HIGH FLOW MACHINE - VAPOTHERM WAS NOTED TO NOT BE WORKING ON A PATIENT. THE MACHINE DID NOT INITIALLY SOUND ALARM. PATIENT REQUIRED FURTHER TREATMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897339 PRECISION FLOW HI-VNI HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE QAV VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male Required Intervention