BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 2188566 · Received August 1, 2011

    Report

    Report Number
    2188566
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 1, 2011
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    NURSE LOOKED UP AND AT A DISTANCE COULD SEE WHAT WAS THOUGHT TO BE SMOKE COMING FROM THE BOTTOM AND SIDES OF THE VAPOTHERM. INITIAL CLOSE UP INVESTIGATION SEEMED LIKE A VAPOR MIST, BUT WITHIN 20 SECONDS THERE WAS A BAD, SMOKEY ODOR. THE VAPOTHERM UNIT THEN ALARMED WITH A YELLOW/ORANGE BOX-TYPE SYMBOL INDICATING "DISPOSABLE WATER PATH FAULTY OR ABSENT." UNIT WAS DISCONNECTED FROM INFANT, THE NASAL CANNULA WAS REMOVED FROM THE BABY AND BLOW-BY WAS GIVEN UNTIL A REGULAR NASAL CANNULA COULD BE APPLIED. BABY DE-SATURATED BRIEFLY BUT REVOVERED QUICKLY WITH THE BLOW-BY AND REGULAR CANNULA. INSPECTION BY CLINICAL ENGINEERING FOUND THAT THE HEATER ASSEMBLY HAD BURNT UP. UNIT WAS RETURNED TO MANUFACTURER FOR EVALUATION.====================== MANUFACTURER RESPONSE FOR HUMIDIFIER, HEAT/MOISTURE EXCHANGE, VAPOTHERM (PER SITE REPORTER)======================MANUFACTURER PROVIDED RETURNED GOODS AUTHORIZATION NUMBER (RGA) FOR DEVICE RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HUMIDIFIER, HEAT/MOISTURE EXCHANGE BTT VAPOTHERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 DA