BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM HIGH FLOW NASAL CANNULA

    MDR report key: 2103471 · Received May 5, 2011

    Report

    Report Number
    2103471
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    VAPOTHERM, INC
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM HIGH FLOW NASAL CANNULA UNIT STOPPED FLOW AND SHUTDOWN. THERAPIST IMMEDIATELY REMOVED PATIENT FROM UNIT AND PLACED ON ANOTHER SYSTEM. WORK ORDER PLACED ON VAPOTHERM UNIT FOR BIOMED ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM HIGH FLOW NASAL CANNULA VAPOTHERM HIGH FLOW NASAL CANNULA BTT VAPOTHERM, INC * 1103013

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO