BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FLOW PLUS

    MDR report key: 18131922 · Received November 13, 2023

    Report

    Report Number
    MW5148100
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 9, 2023
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    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

    VAPOTHERM UNIT SHUT OFF ITSELF WHILE IN PLACE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154205 PRECISION FLOW PLUS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM INC. PFPC00044796E

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Male Required Intervention