BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F&P NEOPUFF

    MDR report key: 24905931 · Received April 16, 2026

    Report

    Report Number
    9611451-2026-01320
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 17, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    UDI-DI
    09420012410979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: THE RD900ALU NEOPUFF INFANT RESUSCITATOR IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, RD900AEU NEOPUFF INFANT RESUSCITATOR IS SOLD IN THE USA. THEREFORE, THE 510(K) NUMBER FOR RD900AEU 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 DISTRIBUTOR IN ITALY REPORTED ON BEHALF OF ANOTHER DISTRIBUTOR VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE GAS OUTLET PORT OF AN RD900ALU NEOPUFF INFANT RESUSCITATOR WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68031 F&P NEOPUFF INFANT RESUSCITATOR FMT FISHER & PAYKEL HEALTHCARE LTD RD900ALU 2100031012 09420012410979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown