BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24812158 · Received April 7, 2026

    Report

    Report Number
    9611451-2026-01182
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 7, 2026
    Report Date
    April 8, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4; COMPLETE DEVICE IDENTIFICATION DETAILS WERE NOT PROVIDED. SECTION G4: THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THAT PRODUCT IS THE 950N40J NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT. THE 510(K) FOR THAT PRODUCT IS K220703. THE SUBJECT DEVICE HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN NORWAY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE INSPIRATORY TUBE OF A 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT WAS FOUND UNDER THE PATIENTS DUVET, AND WAS MOVED TO BE PLACED ON TOP OF THE DUVET. IT WAS REPORTED THAT FOLLOWING THIS THE PATIENT'S OXYGEN SATURATION BEGAN DROPPING, AND UPON INSPECTION, THE INSPIRATORY TUBE WAS FOUND TO HAVE MELTED. THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT WAS THEN REPLACED AND NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610765 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N40

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Unknown F&P HEALTHCARE 950 RESPIRATORY HUMIDIFIER