BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 19295984 · Received May 12, 2024

    Report

    Report Number
    9611451-2024-00356
    Event Type
    Malfunction
    Date Received
    May 12, 2024
    Date of Event
    October 16, 2023
    Report Date
    April 18, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K073706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: SECTION G4: PMA/510(K) NUMBER CORRECTED TO K073706. SECTION H11: METHOD: THE SUBJECT PCB OF THE MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: TESTING OF THE PCB 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). 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.

    Description of Event or Problem · 0

    THE AUDIBLE ALARM OF A MR850AEA RESPIRATORY HUMIDIFIER WAS FOUND TO BE NOT FUNCTIONING. THIS WAS IDENTIFIED DURING A SERVICE CHECK AT OUR FISHER & PAYKEL HEALTHCARE SERVICE CENTRE IN AUSTRALIA. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE AUDIBLE ALARM OF A MR850AEA RESPIRATORY HUMIDIFIER WAS FOUND TO BE NOT FUNCTIONING. THIS WAS IDENTIFIED DURING A SERVICE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842085 RESPIRATORY HUMIDIFIER RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850AEA 060419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown