BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER AND PAYKEL HEALTHCARE

    MDR report key: 23472698 · Received November 4, 2025

    Report

    Report Number
    9611451-2025-01317
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Report Date
    November 5, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850AEA 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 SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED AT OUR FISHER & PAYKEL (F&P) REGIONAL OFFICE IN CHINA WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: PERFORMANCE TESTING OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER CONFIRMED THAT NO SOUND WAS GENERATED FROM THE SPEAKER. ADDITIONAL TESTING IDENTIFIED AN OPEN CIRCUIT IN THE SPEAKER. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING FUNCTIONAL AND ELECTRICAL SAFETY TESTS. CONCLUSION: THE CAUSE OF THE SPEAKER FAILURE WAS AN OPEN CIRCUIT IN THE SPEAKER. 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 CHINA 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
    2678535 FISHER AND PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT BTT FISHER & PAYKEL HEALTHCARE MR850AEA 2102523344 09420012407177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown