BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 1970703 · Received January 11, 2011

    Report

    Report Number
    1970703
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 11, 2011
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM ALARMED, INDICATING A PROBLEM WITH THE DISPOSABLE WATER PATH. UNIT WAS NOT DELIVERING FLOW, SO SUPPLEMENTAL OXYGEN WAS GIVEN DURING THIS TIME. VAPOTHERM WATER PATH WAS CHANGED OUT ALONG WITH THE CIRCUIT. USER CONTINUED TO RECEIVE FAULTY WATER PATH ALARM. ALSO UNIT WAS NOT DELIVERING FLOW. UNIT WAS COMPLETELY CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HIGH FLOW HEAT AND HUMIDIFICATION DEVICE BTT VAPOTHERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA