BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 25053621 · Received April 30, 2026

    Report

    Report Number
    9611451-2026-01540
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 1, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    QAV
    UDI-DI
    09420012466662
    PMA / PMN Number
    K221338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FOR THE SUBJECT DEVICE TO BE RETURNED FOR EVALUATION. 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

    A HEALTHCARE FACILITY IN NEW JERSEY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE 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. 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
    499539 FISHER & PAYKEL HEALTHCARE HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE QAV FISHER & PAYKEL HEALTHCARE LTD PT301US 2103911718 09420012466662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown