BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER AND PAYKEL HEALTHCARE

    MDR report key: 22652675 · Received July 29, 2025

    Report

    Report Number
    9611451-2025-00698
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Report Date
    July 28, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407177
    PMA / PMN Number
    K110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850AEA RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K110019. SECTION D9: DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE NEW ZEALAND ON 06/17/2025. METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED AT OUR FISHER & PAYKEL (F&P) REGIONAL OFFICE IN CHINA WHERE IT WAS INSPECTED BY TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION 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. CONCLUSION: THE ROOT CAUSE OF THE SPEAKER FAULT WAS NOT DETERMINED. THE MR850 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 IS EQUIPPED WITH VISUAL ALARM INDICATORS IN ADDITION TO THE AUDIBLE ALARM.

    Description of Event or Problem · 0

    A DISTRIBUTOR ON BEHALF OF A HEALTHCARE FACILITY 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
    1411563 FISHER AND PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT BTT FISHER & PAYKEL HEALTHCARE MR850AEA 2102524544 09420012407177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown