BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2232147 · Received September 2, 2011

    Report

    Report Number
    9611451-2011-00542
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION FROM THE HEALTHCARE FACILITY WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FOR EVALUATION. ATTEMPTS TO OBTAIN FURTHER INFORMATION AND RETRIEVE THE COMPLAINT DEVICE HAS BEEN UNSUCCESSFUL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: WITHOUT A COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. CONCLUSION: THE CUSTOMER HAS REPORTED THAT A NON FPH BREATHING CIRCUIT WAS USED WITH A FPH MR850 RESPIRATORY HUMIDIFIER. THE ROOT CAUSE CANNOT BE DETERMINED AS NO COMPLAINT DEVICES HAVE BEEN RETURNED TO FPH FOR EVALUATION. IN THE LAST 12 MONTHS FPH HAVE RECEIVED TWO SIMILAR INCIDENCES INVOLVING THIRD PARTY BREATHING CIRCUITS. INVESTIGATION OF THESE COMPLAINTS REVEALED NO FAULTS WITH THE MR850 RESPIRATORY HUMIDIFIERS AND IT IS MOST LIKELY THE CAUSE OF THE INCIDENCES IS RELATED TO THE USE OF BREATHING CIRCUITS NOT APPROVED BY FPH. 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 A WARMED AND HUMIDIFIED. THE MR850 HAS NUMEROUS SAFETY FEATURES WHICH ARE OUTLINED IN THE PRODUCT TECHNICAL MANUAL. OUR USER INSTRUCTIONS STATE THE FOLLOWING: "THE USE OF BREATHING CIRCUITS, CHAMBERS OR OTHER ACCESSORIES WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE MAY IMPAIR PERFORMANCE AND COMPROMISE SAFETY."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER IS "HEATING UP" AND CAUSING THE WATER IN THE CHAMBER TO "BOIL" AND THE PULMONETICS NON-HEATED BREATHING CIRCUIT TO DEFORM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER IS "HEATING UP" AND CAUSING THE WATER IN THE CHAMBER TO "BOIL" AND THE PULMONETICS NON-HEATED BREATHING CIRCUIT TO DEFORM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 080317

    Patients

    Seq Age Sex Outcome Treatment
    1 PULMONETICS NON-HEATED BREATHING CIRCUIT| PULMONETICS NON-HEATED BREATHING CIRCUIT| PULMONETICS LTV| PULMONETICS LTV