BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24381598 · Received February 18, 2026

    Report

    Report Number
    9611451-2026-00576
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Report Date
    April 9, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012450029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. FISHER & PAYKEL (F&P) HEALTHCARE IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. METHOD: THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT, ADDITIONAL INFORMATION, AND PHOTOGRAPHS WERE REQUESTED TO BE PROVIDED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT, WAS NOT PROVIDED TO F&P HEALTHCARE FOR EVALUATION. VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH INDICATED THE LOCATION OF THE LOOSE CONNECTOR AT THE PATIENT END OF THE INSPIRATORY LIMB. HOWEVER, THE REPORTED ISSUE COULD NOT BE CONFIRMED. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND WITHOUT THE RETURN OF THE SUBJECT DEVICE, F&P HEALTHCARE'S INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. ALL 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION, INCLUDING A 100% LEAK TEST DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANIES THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT MAY ALSO CAUTION THE USER: - SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT A 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS FOUND WITH A LOOSE CONNECTOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT A 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS FOUND WITH A LOOSE CONNECTOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472224 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N81 2103918125 09420012450029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown