BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 5113791 · Received September 23, 2015

    Report

    Report Number
    MW5056622
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 4, 2015
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ON VAPOTHERM AND THE LITER FLOW WHICH WAS FOUND TO BE INSUFFICIENT AT SETTINGS OF 51PM. AT 1630 ON 08/11/2015 THE PT WAS PLACED ON VAPOTHERM AT 5 LITERS PER MINUTE AND 100% FIO2. AT 1839 ARTERIAL BLOOD GASES WERE 7.30 PH, 48 CO2, 75 PO2. AT 1900, SPO2 96%, HR 142, RR 81. HEART RATE WAS 13, REPARATORY RATE WAS 35 WITH O2 SATS OF 99. PT PLACED ON REPLACEMENT VAPOTHERM AND THEN RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629845 VAPOTHERM VAPOTHERM BTT VAPOTHERM INC. PRECISION FLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA