BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23752472 · Received December 8, 2025

    Report

    Report Number
    9611451-2025-01851
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 10, 2025
    Report Date
    March 16, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012422354
    Removal / Correction Number
    9611451-09/10/2025-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT101UK IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT101US). THE 510(K) FOR THE SIMILAR PRODUCT IS K131895. 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 PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) IS AN ACTIVE HUMIDIFIER WITH INTEGRATED FLOW GENERATOR THAT DELIVERS HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES TO SPONTANEOUSLY BREATHING PATIENTS THROUGH A VARIETY OF PATIENT INTERFACES. ITS INTENDED USE IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO 2 IS NOT INTENDED FOR LIFE SUPPORT, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES.

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT101UK IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT101US). THE 510(K) FOR THE SIMILAR PRODUCT IS K131895. CORRECTED DATA: B4, B5, D9, G3, G6, H2, H6. PRODUCT BACKGROUND: THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) IS AN ACTIVE HUMIDIFIER WITH INTEGRATED FLOW GENERATOR THAT DELIVERS HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES TO SPONTANEOUSLY BREATHING PATIENTS THROUGH A VARIETY OF PATIENT INTERFACES. ITS INTENDED USE IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO 2 IS NOT INTENDED FOR LIFE SUPPORT, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES. METHOD: THE SUBJECT AIRVO 2 WAS RECEIVED AT THE FISHER & PAYKEL HEALTHCARE (F&P) REGIONAL OFFICE IN THE UNITED KINGDOM WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN AND THE POWER OUT ALARM FUNCTIONALITY WAS CHECKED. RESULTS: DURING TESTING IT WAS FOUND THAT THE POWER OUT ALARM OF THE AIRVO 2 SOUNDED FOR A MINIMUM OF 120 SECONDS. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT. CONCLUSION: F&P ARE UNABLE TO CONFIRM WHAT MAY HAVE CAUSED THE REPORTED EVENT AS THE POWER OUT ALARM OF THE RETURNED DEVICE SOUNDED FOR A MINIMUM OF 120 SECONDS.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER OUT ALARM OF THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE AIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE POWER OUT ALARM OF THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) SOUNDED FOR LESS THAN 120 SECONDS. THIS WAS FOUND WHILE THE SUBJECT AIRVO 2 WAS OUT OF USE AND NOT ON A PATIENT. THIS WAS REPORTED SUBSEQUENT TO A FIELD SAFETY NOTICE INFORMING USERS OF A CHANGE TO THE DISINFECTION KIT USER MANUAL OF THE AIRVO 2 TO INCLUDE A REGULAR TEST OF THE POWER OUT ALARM, TO BE CARRIED OUT IN BETWEEN EACH PATIENT USE. 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
    2814580 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101UK 2103190872 09420012422354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown