BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 15741380 · Received November 6, 2022

    Report

    Report Number
    9611451-2022-01036
    Event Type
    Malfunction
    Date Received
    November 6, 2022
    Report Date
    October 17, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF FINALISING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT MR850 RESPIRATORY HUMIDIFIER WAS RETURNED TO OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN FRANCE WHERE IT WAS INSPECTED BY A TRAINED F&P SERVICE TECHNICIAN. THE DEVICE WAS THEN REPAIRED AND RETURNED TO THE CUSTOMER. RESULTS: PERFORMANCE TESTING OF THE RETURNED MR850 RESPIRATORY HUMIDIFIER CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING PROPERLY. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE MALFUNCTIONING AUDIBLE ALARM. OUR MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 HEATER BASE. 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 HEALTHCARE FACILITY IN FRANCE REPORTED AN ISSUE WITH A MR850 RESPIRATORY HUMIDIFIER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED AN ISSUE WITH A MR850 RESPIRATORY HUMIDIFIER. UPON DEVICE SERVICING AT THE REGIONAL OFFICE IN FRANCE, IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251464 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 2101362992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown