BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24142903 · Received January 22, 2026

    Report

    Report Number
    9611451-2026-00314
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 21, 2025
    Report Date
    January 22, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    UDI-DI
    09420012469717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT301CA IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT301US). THE 510(K) FOR THE SIMILAR PRODUCT IS K221338. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING F&P'S INVESTIGATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE PT301 HUMIDIFIER (AIRVO 3) IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THIS INCLUDES PATIENTS WHO HAVE HAD UPPER AIRWAYS BYPASSED. THE FLOW MAY BE FROM 2 - 70 L/MIN DEPENDING ON THE PATIENT INTERFACE. THE AIRVO 3 IS FOR PATIENTS IN HOSPITALS AND SUBACUTE FACILITIES. THE AIRVO 3 IS NOT INTENDED FOR LIFE SUPPORT. THE AIRVO 3 CAN DELIVER THESE HIGH FLOW GASES THROUGH NASAL CANNULA TO AUGMENT THE BREATHING OF SPONTANEOUSLY BREATHING NEONATE, INFANT, CHILD, ADOLESCENT AND ADULT PATIENTS SUFFERING FROM RESPIRATORY DISTRESS AND/OR HYPOXEMIA IN THE HOSPITAL SETTING. THE AIRVO 3 IS NOT INTENDED TO PROVIDE TOTAL VENTILATORY REQUIREMENTS OF THE PATIENT AND IS NOT FOR USE DURING FIELD TRANSPORT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PT301 AIRVO 3 GENERATED AN ALARM. THE NATURE OF THE ALARM SUGGESTS THERE MAY BE A POTENTIAL ISSUE WITH THE SUBJECT DEVICE'S AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE SUBJECT DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206022 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER QAV FISHER & PAYKEL HEALTHCARE LTD PT301CA 2102456058 09420012469717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown