BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19848727 · Received July 28, 2024

    Report

    Report Number
    9611451-2024-00546
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Report Date
    July 1, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012407276
    PMA / PMN Number
    K110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SUBJECT MR850 RESPIRATORY HUMIDIFIER HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE SECTION G4: THE MR850GJU IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K110019 METHOD: THE SPEAKER OF THE SUBJECT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: TESTING OF THE SPEAKER 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.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED 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 JAPAN 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
    1036683 FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850GJU 2101864669 09420012407276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown