BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21639105 · Received March 18, 2025

    Report

    Report Number
    9611451-2025-00048
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Report Date
    December 20, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012407276
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE MR850GJU 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 H11: METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RECEIVED AT OUR FISHER & PAYKEL (F&P) REGIONAL OFFICE IN JAPAN WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. THE UNIT WAS SERVICED AND PERFORMANCE TESTED. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE F&P HEALTHCARE SERVICE TECHNICIAN, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: TESTING OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER REVEALED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING PROPERLY. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING FUNCTIONAL AND ELECTRICAL SAFETY TESTS. CONCLUSION: 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 JAPAN REPORTED THAT AN MR850JHU RESPIRATORY HUMIDIFIER WAS FAULTY. UPON SERVICING AT THE FISHER & PAYKEL (F&P) HEALTHCARE REGIONAL SERVICE CENTRE, IT WAS FOUND THAT THE AUDIBLE SPEAKER WAS NOT FUNCTIONING PROPERLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285064 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850GJU 2100735113 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown