BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1960509 · Received January 13, 2011

    Report

    Report Number
    9611451-2011-00029
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR850JHU RESPIRATORY HUMIDIFIER WAS NOT RETURNED TO FPH (B)(4) FOR INVESTIGATION. OUR ANALYSIS IS BASED ON THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION PROVIDED BY THE MEDICAL CENTER. RESULTS: THE MEDICAL CENTER REPORTED THAT ONE OF THEIR BIOMEDS "DID BENCH TEST THE 850 HEATER USING ALL OF THE F&P TEST PROCEDURES". THE MR850 HUMIDIFIER PASSED ALL THE PERFORMANCE CHECKS AND WAS PUT BACK INTO GENERAL SERVICE. CONCLUSION: NO FAULT WAS FOUND WITH THE MR850JHU HUMIDIFIER. IT PASSED THE PERFORMANCE CHECKS CONDUCTED BY THE BIOMED OF THE MEDICAL CENTER. 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".

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE MEDICAL CENTER IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CLINICAL PRODUCT SPECIALIST THAT THE EXPIRATORY TUBE OF AN AIRLIFE RT509-852 PEDIATRIC CIRCUIT (WITH LOT NUMBER Y10J1426) MELTED WHILE IT WAS BEING USED WITH AN FPH MR850JHU RESPIRATORY HUMIDIFIER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) CLINICAL PRODUCT SPECIALIST THAT THE EXPIRATORY TUBE OF AN AIRLIFE RT509-852 PEDIATRIC CIRCUIT (WITH LOT NUMBER Y10J1426) MELTED WHILE IT WAS BEING USED WITH AN FPH MR850JHU RESPIRATORY HUMIDIFIER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1