BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24946670 · Received April 21, 2026

    Report

    Report Number
    9611451-2026-01353
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 22, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE 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. 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.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN JAPAN REPORTED ON BEHALF OF ANOTHER HEALTHCARE FACILITY VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT A 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS FOUND TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521666 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown