BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23009511 · Received September 9, 2025

    Report

    Report Number
    9611451-2025-00862
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Report Date
    December 3, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION D4: DEVICE INDENTIFICATION DETAILS WERE NOT RECEIVED. SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. METHOD: THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE KNOWLEDGE OF OUR PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THAT THE CONNECTION OF THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO THE PRESSURE LINE WOULD DETACH DURING PATIENT USE. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED FAILURE. ALL 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT STATES: -"CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." -"PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." -"SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CONNECTION OF THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO THEPRESSURE LINE WOULD DETACH DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CONNECTION OF THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT TO THE PRESSURE LINE WOULD DETACH DURING PATIENT USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831664 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT KIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P 950 RESPIRATORY HUMIDIFIER.