BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MR850

    MDR report key: 24705936 · Received March 26, 2026

    Report

    Report Number
    9611451-2026-01091
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Report Date
    March 27, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407276
    PMA / PMN Number
    K110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850GJU 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 K110019. 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 MR850GJU RESPIRATORY HUMIDIFIER TO F&P HEALTHCARE NEW ZEALAND FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY, THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767576 MR850 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE MR850GJU 2101579373 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown