BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM PRECISION FLOW

    MDR report key: 18776841 · Received February 26, 2024

    Report

    Report Number
    18776841
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 1, 2024
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE VAPOTHERM WAS SET UP APPROPRIATELY AND FLOW WAS CONFIRMED. SHORTLY AFTERWARDS, THE PATIENT BEGAN EXHIBITING SIGNS OF RESPIRATORY DISTRESS. AN EMERGENCY RESPONSE WAS ACTIVATED DURING WHICH, IT WAS NOTED THAT THE VAPOTHERM DISPLAY WAS NOT ILLUMINATED. THE NUMERICAL DISPLAY WAS RESTORED AFTER INTERACTING WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001551 VAPOTHERM PRECISION FLOW HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM INC. PRECISION FLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Female Required Intervention| L