BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FLOW

    MDR report key: 22062701 · Received May 21, 2025

    Report

    Report Number
    MW5170675
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 16, 2025
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VAPOTHERM MALFUNCTIONED. PATIENT WAS USING THE EQUIPMENT WHEN IT SHUT OFF. NURSING ABLE TO DUPLICATE. BIOMED NOT ABLE TO REPLICATE. TESTING IS NEEDED ON THIS EQUIPMENT EVERY 6 MONTHS, THAT WAS COMPLETED IN DECEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366778 PRECISION FLOW HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention