BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER AND PAYKEL HEALTHCARE

    MDR report key: 23472493 · Received November 4, 2025

    Report

    Report Number
    9611451-2025-01314
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Report Date
    March 16, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407238
    PMA / PMN Number
    K110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION B4:DATE OF THIS REPORT UPDATED. SECTION G4: THE MR850AGU 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 CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: PERFORMANCE TESTING OF THE PCB FROM THE SUBJECT MR850 RESPIRATORY HUMIDIFIER 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.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850AGU 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. THE SUBJECT MR850 RESPIRATORY HUMIDIFIER 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 HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN GERMANY 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
    2693474 FISHER AND PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE MR850AGU 2102146397 09420012407238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown