BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F&P NEOPUFF

    MDR report key: 24230857 · Received February 2, 2026

    Report

    Report Number
    9611451-2026-00413
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Report Date
    May 8, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012410993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4(PREMARKET IDENTIFICATION FIELD): RD900ANU 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 K971695. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN BELGIUM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN RD900ANU NEOPUFF INFANT RESUSCITATOR (SUBJECT DEVICE) FAILED THE VALVE TEST. IT WAS FURTHER REPORTED THAT THE NEEDLE OF SUBJECT DEVICE'S MANOMETER WOULD GO BACK TO ZERO CMH2O WITH SLOW MOVEMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372192 F&P NEOPUFF NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900ANU 2100649625 09420012410993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown