BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 25037589 · Received April 29, 2026

    Report

    Report Number
    9611451-2026-01427
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 30, 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 D4: COMPLETE DEVICE IDENTIFICATION INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. SECTION G4: THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT 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. SECTION H11: FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE HAVE ALSO REQUESTED THE RETURN OF THE SUBJECT 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT TO F&P HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT WAS FOUND DAMAGED AND FAILED THE VENTILATOR LEAK TEST DURING SETUP AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294731 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown