BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 6169063 · Received December 13, 2016

    Report

    Report Number
    6169063
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 2, 2016
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    YELLOW TRIANGLE WITH EXCLAMATION POINT ERROR OCCURRED ON VAPOTHERM WHILE ON PATIENT. THE ERROR CLEARED WHEN RESTARTED, BUT FIO2 UNSTABLE AND DRIFTING TO 21% WHEN SET AT 100%. THE VAPOTHERM TECHNICAL SUPPORT INDICATED FAILURE OF MAIN BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822657 PRECISION FLOW HUMIDIFIER, RESPIRATORY GAS BTT VAPOTHERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO