BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24217864 · Received January 29, 2026

    Report

    Report Number
    9611451-2026-00393
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    May 23, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    UDI-DI
    09420012459688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). D4, G4: PT301AN 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 PT301US 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 AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER CORD AS PART OF THE PT301US AIRVO 3 HUMIDIFIER WAS FOUND DAMAGED WITH PARTIALLY MELTED INSULATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541574 FISHER & PAYKEL HEALTHCARE HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE QAV FISHER & PAYKEL HEALTHCARE LTD PT301AN 2103042073 09420012459688

    Patients

    Seq Age Sex Outcome Treatment
    1