BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24891991 · Received April 15, 2026

    Report

    Report Number
    9611451-2026-01280
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 16, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCAREE LTD
    Product Code
    BTT
    UDI-DI
    09420012450029102102575494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SINGAPORE, VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE EXPIRATORY LIMB OF AN 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WAS FOUND TO BE DAMAGED, WITH A HOLE AND WATER LEAKAGE OBSERVED DURING PATIENT USE. THE HEALTHCARE FACILITY REPORTED THAT THE REPORTED ISSUE WAS OBSERVED ON DAY 22 OF USE.THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493106 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCAREE LTD 950N81 2102575494 09420012450029102102575494

    Patients

    Seq Age Sex Outcome Treatment
    1