BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20803074 · Received November 27, 2024

    Report

    Report Number
    9611451-2024-00877
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Report Date
    November 5, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012407276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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 K073706. METHOD: THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: TESTING OF THE DEVICE CONFIRMED THAT NO SOUND WAS GENERATED FROM THE SPEAKER. ADDITIONAL RESISTANCE TESTING IDENTIFIED AN OPEN CIRCUIT IN THE SPEAKER'S COIL. CONCLUSION: THE CAUSE OF THE SPEAKER FAILURE WAS AN OPEN CIRCUIT CONDITION OF THE SPEAKER COIL. 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.

    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 K073706. THE SPEAKER OF THE SUBJECT MR850GJU 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.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED A FAULT WITH AN MR850 RESPIRATORY HUMIDIFIER. UPON SERVICING AT THE (B)(6), IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED A FAULT WITH AN MR850 RESPIRATORY HUMIDIFIER. UPON SERVICING AT THE REGIONAL SERVICE CENTRE, IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2612529 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850GJU 2101500513 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown