BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2337383 · Received November 15, 2011

    Report

    Report Number
    9611451-2011-00705
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Report Date
    October 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); 900MR805 HEATER WIRE ADAPTER - LOT 090612, DEVICE MANUFACTURE DATE - 06/12/2009; 900MR869 TEMPERATURE PROBE - LOT 100909, DEVICE MANUFACTURE DATE - 09/09/2010. METHOD: THE COMPLAINT RESPIRATORY HUMIDIFIER WAS RETURNED ALONG WITH THE 900MR805 HEATER WIRE ADAPTER AND 900MR869 TEMPERATURE PROBE USED IN THE SET UP. THE RETURNED DEVICES WERE PERFORMANCE TESTED. THE COMPLAINT BREATHING CIRCUIT HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE. RESULTS: THE RETURNED DEVICES WERE PERFORMANCE TESTED AND THEY FUNCTIONED AS INTENDED WITH NO FAULT FOUND. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT DEVICES. THE CUSTOMER HAS REPORTED THAT A NON FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT WAS USED IN THE SET UP. THE ROOT CAUSE CANNOT BE DETERMINED AS THE COMPLAINT BREATHING CIRCUIT WAS NOT RETURNED. THE MR850 RESPIRATORY HUMIDIFIER IS DESIGNED TO ADD HEAT OR MOISTURE TO RESPIRATORY GASES. THE GAS IS PASSED THROUGH A HUMIDIFICATION CHAMBER WHERE IT IS WARMED AND HUMIDIFIED. THE MR850 HAS NUMEROUS SAFETY FEATURES WHICH ARE OUTLINED IN THE PRODUCT TECHNICAL MANUAL. THE MR850 PRODUCT TECHNICAL MANUAL SPECIFIES THE FOLLOWING IN THE WARNING SECTION: "THE USE OF BREATHING CIRCUITS, CHAMBERS OR OTHER ACCESSORIES, WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE, MAY IMPAIR PERFORMANCE OR COMPROMISE SAFETY". THE HOSPITAL HAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE, (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED WHAT APPEARED TO BE A HOLE MELTED IN THE EXPIRATORY LIMB OF THE AIRLIFE BREATHING CIRCUIT AFTER ONE DAY OF USE WITH A FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, WHICH CAUSED THE VENTILATOR TO ALARM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED WHAT APPEARED TO BE A HOLE MELTED IN THE EXPIRATORY LIMB OF THE AIRLIFE BREATHING CIRCUIT AFTER ONE DAY OF USE WITH A FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, WHICH CAUSED THE VENTILATOR TO ALARM. THE HOSPITAL HAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850JHU 100812

    Patients

    Seq Age Sex Outcome Treatment
    1 900MR805 HEATERWIRE ADAPTER| 900MR869 TEMPERATURE PROBE