BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER AND PAYKEL HEALTHCARE

    MDR report key: 23600996 · Received November 19, 2025

    Report

    Report Number
    9611451-2025-01596
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Report Date
    February 13, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. WE HAVE REQUESTED THE RETURN OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(6). CORRECTIONS: SECTION A1: PATIENT IDENTIFIER UPDATED. SECTION D2A: COMMON DEVICE NAME UPDATED. SECTION D4: EXPIRATION DATE REMOVED. SECTION H4: DEVICE MANUFACTURER DATE UPDATED. 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. METHOD: THE SPEAKER FROM THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED AT FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS PERFORMANCE TESTED. OUR INVESTIGATION IS THUS BASED ON THE EVALUATION OF THE SUBJECT DEVICE, THE INFORMATION PROVIDED BY THE DISTRIBUTOR, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: PERFORMANCE TESTING OF THE RETURNED SPEAKER CONFIRMED THAT NO SOUND WAS GENERATED FROM THE SPEAKER. RESISTANCE TESTING IDENTIFIED AN OPEN CIRCUIT IN THE SPEAKER'S COIL. CONCLUSION: THE ROOT CAUSE OF THE SPEAKER FAILURE WAS DUE TO AN OPEN CIRCUIT IN THE SPEAKER COIL. THE MR850 RESPIRATORY HUMIDIFIER PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 RESPIRATORY HUMIDIFIER. IN ADDITION, THE PRODUCT TECHNICAL MANUAL ALSO STATES THAT "ALL SERVICING PROCEDURES SHOULD BE FOLLOWED BY A HUMIDIFIER TEST, AND AN ELECTRICAL SAFETY TEST TO ENSURE PROPER OPERATION". THE MR850 RESPIRATORY HUMIDIFIER IS EQUIPPED WITH VISUAL ALARM INDICATORS IN ADDITION TO THE AUDIBLE ALARM.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF A MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293284 FISHER AND PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE MR850GJU 2101833799 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown