BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM PATIENT CIRCUIT

    MDR report key: 2624832 · Received June 9, 2012

    Report

    Report Number
    2624832
    Event Type
    Malfunction
    Date Received
    June 9, 2012
    Date of Event
    April 4, 2012
    Report Date
    June 6, 2012
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT 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 PATIENT'S NOSE. THE VAPOTHERM WAS REMOVED FROM THE PATIENT AND INSPECTED BY RT. IT WAS FOUND TO BE PERIODICALLY SPRAYING WATER OUT OF THE CIRCUIT WHERE THE CANNULA CONNECTS. PATIENT WAS PLACED ON A DIFFERENT NASAL CANNULA AND THE CIRCUIT WAS REMOVED FROM THE VAPOTHERM AND THE RT SUPERVISOR WAS NOTIFIED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM PATIENT CIRCUIT CANNULA, NASAL HIGH FLOW BTT VAPOTHERM, INC. PF-DPC-LOW LF-1202007

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO