BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 7147434 · Received December 27, 2017

    Report

    Report Number
    7147434
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 21, 2017
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RAPID RESPONSE WAS CALLED OVER HEAD FOR PT. RAPID RESPONSE ENTERED PT ROOM AND PT WAS DISORIENTED. IT WAS NOT POSSIBLE TO OBTAIN A GOOD SPO2 ON PT. THE AMBU BAG WAS GRABBED AND STARTED BAGGING PT. RN STATED THAT THE VAPOTHERM WAS ALARMING. I WAS UNABLE TO SEE THE VAPOTHERM FROM HEAD OF BED AND CONTINUED BAGGING PT AT FLUSH. WE WERE ABLE TO GET A SPO2 ON THE PT, WHICH STARTED AROUND SPO2 OF 65%. AFTER A COUPLE OF MINUTES OF BAGGING, PT'S SPO2 WAS 95%. PT WAS PLACED ON HIGH-FLOW NASAL CANNULA (HFNC) AT 15L 95%. PT IS BEING TRANSFERRED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926283 VAPOTHERM HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VAPOTHERM, INC. PF-PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other