BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM PRECISION FLOW HUMIDIFIER

    MDR report key: 4942062 · Received July 20, 2015

    Report

    Report Number
    4942062
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    May 28, 2015
    Report Date
    July 20, 2015
    Manufacturer
    VAPOTHERM, INC
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING THE FIRST ROUND OF PMS ON VAPOTHERM PRECISION FLOW HUMIDIFIER, IT WAS FOUND THE UNITS WERE HAVING A DIFFICULT TIME REACHING MAXIMUM TEMPERATURE PER THE MANUFACTURER'S SPECIFICATIONS. THE SPECIFICATIONS STATE THE UNIT WILL REACH A MAX TEMP OF 43C +/-2C AT THE DISTAL END OF THE PATIENT CIRCUIT.TESTS ON 5 DIFFERENT VAPOTHERMS AT THE DISTAL END SHOWED READINGS OF 39C-41C WITH 3 DIFFERENT THERMOMETERS. THE VAPOTHERM DISPLAY ALWAYS SHOWS 43C. PM TESTS FAILED TO REACH THE MAX LIMIT WITHOUT RAISING THE AMBIENT TEMPERATURE OF THE TEST LABS.MANUFACTURER WAS MADE AWARE AND THE ROOT CAUSE WAS DEEMED TO BE IN THE DPC INTERFACE WITH THE HEATER PLATE. NEW DISPOSABLE CASSETTES ARE BEING MANUFACTURED TO MEET THE TECHNICAL SPECIFICATIONS.======================MANUFACTURER RESPONSE FOR PATIENT HUMIDIFIER, VAPOTHERM PRECISION FLOW HUMIDIFIER (PER SITE REPORTER).======================MANUFACTURER WAS VERY RESPONSIVE IN INVESTIGATING THE PM ISSUE. HOWEVER, THE DETAILS AND ROOT CAUSE WERE GIVEN VIA A PHONE CALL AND NOT IN WRITING. THE MANUFACTURER DETERMINED THE ISSUE TO BE DUE TO THE DPC INTERFACE WITH THE HEATER PLATE, WHICH WAS NOT ABLE TO MAINTAIN THE TEMPERATURE WITHOUT AMBIENT TEMPERATURE BEING HIGH ENOUGH TO FACILITATE MAX LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469119 VAPOTHERM PRECISION FLOW HUMIDIFIER HUMIDIFIER BTT VAPOTHERM, INC 85-PF *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER DEVICES