BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2749567 · Received September 18, 2012

    Report

    Report Number
    9611451-2012-00647
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    April 5, 2012
    Report Date
    August 22, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT204 ADULT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMLIAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT204 BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. PHOTOGRAPHS OF THE FAULTY CIRCUITS WERE REQUESTED, BUT THESE WERE NOT PROVIDED. OUR INVESTIGATION IS THEREFORE BASED ON THE DESCRIPTION OF THE PROBLEM AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: BASED ON OTHER COMPLAINTS OF THIS NATURE THAT WE HAVE RECEIVED, WHEN THE HEATER WIRE ADAPTOR CANNOT BE FULLY CONNECTED TO THE HEATER WIRE SOCKET IN THE HEATED INSPIRATORY TUBE OF THE RT204, WE USUALLY FIND THAT ONE OR BOTH OF THE INSPIRATORY HEATER WIRE PINS ARE BENT OR SPLIT. THIS PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET. DETAILS OF THE LOT NUMBERS AND QUANTITIES INVOLVED IN THIS REPORT: LOT 110809, QUANTITY 1, MANUFACTURED 9 AUGUST 2011; LOT 110923, QUANTITY 2, MANUFACTURED 23 SEPTEMBER 2011; LOT 110926, QUANTITY 3, MANUFACTURED 26 SEPTEMBER 2011; LOT 111116, QUANTITY 2, MANUFACTURED 16 NOVEMBER 2011; LOT 120306, QUANTITY 1, MANUFACTURED 6 MARCH 2012; PLUS 2 WITH LOT NUMBER UNKNOWN. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE RT204 FOR ANY OF THE LOT NUMBERS PROVIDED. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO DAMAGE THE HEATER WIRE PINS DURING USE, FOR EXAMPLE, IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT PINS REPORTED TO US BY HEALTH CARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING TRANSPORT OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE HEATER WIRE PINS WERE DAMAGED ON THE INSPIRATORY LIMB OF 11 RT204 ADULT BREATHING CIRCUITS, PREVENTING CONNECTION OF THE BREATHING CIRCUIT TO THE HEATER WIRE ADAPTOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT204 110809

    Patients

    Seq Age Sex Outcome Treatment
    1