BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT FLO

    MDR report key: 2233354 · Received August 30, 2011

    Report

    Report Number
    2233354
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 25, 2011
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT AROUND 1545, MOTHER OF THE BABY WAS BREASTFEEDING WHEN ALL OF A SUDDDEN THE HUMIDIFIER OF THE HIGH FLOW NASAL CANNULA (HFNC) STARTED SPEWING WATER. IT STARTED WITH A TINY MIST AND THE RN TOOK THE CANNULA OFF THE BABY'S FACE. IT THEN CONTINUED TO SPEW WATER WITH A LOT OF FORCE EVEN WHEN THE HEATER WAS TURNED OFF. CLINICIANS SUCTIONED THE BABY'S MOUTH AND MOM, WHO'S AN RN, CONTINUED WITH THE SUCTIONING WHILE ANOTHER RN PREPARED THE BLOW BY AND SWITCHED TO A HUMIDIFIED NASAL CANNULA. THIS WAS TOLERATED BY THE BABY WELL AND NO RESPIRATORY DISTRESS WAS NOTED. THE DOCTOR AT THE BEDSIDE WITNESSED THE INCIDENT. THE RT WAS MADE AWARE AND CHANGED THE HFNC SET UP. PER MOM, SAME INCIDENT HAPPENED THE NIGHT BEFORE. RT SUPERVISOR CAME AS WELL AND SPOKE WITH MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT FLO HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT TELEFLEX * 02F11-01710

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY PRENATAL MEDICATION