BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20888673 · Received December 10, 2024

    Report

    Report Number
    9611451-2024-00924
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Report Date
    November 13, 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
    Health Professional
    N

    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. 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. 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.

    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. THE SUBJECT MR850 RESPIRATORY HUMIDIFIER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED 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 DISTRIBUTOR IN JAPAN REPORTED THAT THE AUDIBLE ALARM OF AN MR850 RESPIRATORY HUMIDIFIER WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502562 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850GJU 2101326570 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown