BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM HI-VNI

    MDR report key: 19683845 · Received July 3, 2024

    Report

    Report Number
    MW5157042
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 1, 2024
    Manufacturer
    VAPOTHERM INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VAPOTHERM OXYGEN WAS ALARMING. NURSE RESPONDED TO ALARM AND NOTED THAT NO AIR FLOW WAS COMING OUT OF THE MACHINE. NON-REBREATHER OXYGEN MASK OBTAINED IMMEDIATELY AND PLACED ON PATIENT AT 15 L OXYGEN. ATTEMPTED TO TROUBLESHOOT HIGH FLOW MACHINE. RESPIRATORY THERAPY TO BEDSIDE AND FIXED OXYGEN FLOW ON HIGH FLOW MACHINE. PATIENT REMAINED STABLE AND THEN WAS PLACED BACK ON HIGH FLOW NASAL CANNULA OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152400 VAPOTHERM HI-VNI REGULATOR, PRESSURE, GAS CYLINDER CAN VAPOTHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention