BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER AND PAYKEL HEALTHCARE

    MDR report key: 23106417 · Received September 22, 2025

    Report

    Report Number
    9611451-2025-00916
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Report Date
    October 21, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    UDI-DI
    09420012407207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: THE MR850AEU 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.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850AEU 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 NOT SENT TO FISHER AND PAYKEL (F&P) HEALTHCARE FOR INVESTIGATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS NOT GENERATING AN AUDIBLE ALARM. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, THE ROOT CAUSE OF THE SPEAKER FAULT WAS NOT DETERMINED. 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 TURKEY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE REPRESENTATIVE 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 TURKEY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE REPRESENTATIVE 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
    2655146 FISHER AND PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT BTT FISHER & PAYKEL HEALTHCARE MR850AEU 2102268126 09420012407207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown