BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM DISPOSABLE PT CIRCUIT

    MDR report key: 2810200 · Received October 3, 2012

    Report

    Report Number
    1125759-2012-00003
    Event Type
    Other
    Date Received
    October 3, 2012
    Date of Event
    April 4, 2012
    Report Date
    October 3, 2012
    Manufacturer
    VAPOTHERM, INC
    Product Code
    BTT
    PMA / PMN Number
    K072845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER'S RESPONSE: WE RECEIVED A REPORT FROM THE CUSTOMER REGARDING WATER COMING THROUGH THE CANNULA. WE INVESTIGATED THE DISPOSABLE PT CIRCUIT AND FOUND THAT THE LEAK RATE WAS 3 MILLILITERS/HOUR. WE WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE APPROPRIATE ACTION AS NECESSARY. EVENT DESCRIPTION: PT WAS ON THE VAPOTHERM HIGH FLOW NASAL CANNULA RECEIVING CARE FROM PT WHEN IT WAS NOTICED THAT WATER WAS COMING THROUGH THE CANNULA AND SPRAYING INTO THE PT'S NOSE. THE VAPOTHERM WAS REMOVED FROM THE PT AND INSPECTED BY RT. IT WAS FOUND TO BE PERIODICALLY SPRAYING WATER OUT OF THE CIRCUIT WHERE THE CANNULA CONNECTS. PT WAS PLACED ON A DIFFERENT NASAL CANNULA AND THE CIRCUIT WAS REMOVED FORM THE CAPOTHERM AND THE RT SUPERVISOR WAS NOTIFIED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM DISPOSABLE PT CIRCUIT PF-DPC-LOW BTT VAPOTHERM, INC PF-DPC-LOW LF1202007

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other