BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUDSON RCI PREFILLED HUMIDIFIER

    MDR report key: 17499581 · Received August 9, 2023

    Report

    Report Number
    MW5122892
    Event Type
    Other
    Date Received
    August 9, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 7, 2023
    Manufacturer
    MEDLINE INDUSTRIES-ARLINGTON HEIGHTS
    Product Code
    BTT
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED HER NOSE WAS DRY AND WAS ON 4L HIGH FLOW NASAL CANNULA. RN TITRATED PATIENT TO 3L AND CHANGED NASAL CANNULA TO REGULAR AND ADDED HUMIDIFICATION (DISCUSSED WITH RT). RN SET UP NEW SYSTEM (SEE BELOW). AFTER RN SET UP TUBING AND TURNED O2 TO 3L, PATIENT REPORTED "DROWNING." SHE REMOVED HER NASAL CANNULA, LIQUID FROM HUMIDIFIER WAS POURING OUT THROUGH THE NASAL PRONGS, GOWN WAS WET, CANNULA WAS FILLED WITH WATER FROM BUBBLER. PATIENT COUGHING, OXYGEN SAT STABLE. PATIENT STATED SHE WAS OK. HUDSON RCI PREFILLED HUMIDIFIER 340ML ,LOT 23B141, REF: RHP340U, 2023-03-29, 2027-03-29, L02552 R01 (7/20) INCLUDING ADAPTOR AIRLIFE, ADULT CUSHION NASAL CANNULA25FT NASAL CANNULA REF: SFT2625U, LOT 0004225427, 2025-08-04 AIRLIFE, SMOOTH BORE OXYGEN TUBING 7FT, REF 001330U, LOT 0004209655, 2025-02-11 NASAL CANNULA EXTENDER CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050054 HUDSON RCI PREFILLED HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT MEDLINE INDUSTRIES-ARLINGTON HEIGHTS RHP340U 23B141

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown AIRLIFE NASAL CANNULA SFT2625U.| AIRLIFE SMOOTH BOR OXYGEN TUBING 001330U.