BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23901581 · Received December 27, 2025

    Report

    Report Number
    9611451-2025-01714
    Event Type
    Malfunction
    Date Received
    December 27, 2025
    Report Date
    December 28, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    UDI-DI
    09420012469762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT301IN 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 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

    AN OFFICE IN INDIA REPORTED THAT A PT301 AIRVO 3 HUMIDIFIER (AIRVO 3) GENERATED A VISUAL ALARM. THE NATURE OF THE VISUAL ALARM SUGGESTS THERE MAY BE A POTENTIAL ISSUE WITH THE SUBJECT DEVICE'S AUDIBLE ALARM. DURING DEVICE EVALUATION AT THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE INDIA, IT WAS FOUND THAT THERE WAS NO AUDIBLE ALARM. THERE WAS NO 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
    2564636 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER QAV FISHER & PAYKEL HEALTHCARE LTD PT301IN 2102188245 09420012469762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown