BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 2749585 · Received September 18, 2012

    Report

    Report Number
    9611451-2012-00645
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Report Date
    August 20, 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 RT226 INFANT LOW FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. LOT NUMBERS (QUANTITY) AND DEVICE MANUFACTURER DATE: 120113 (3) - 01/13/2012; 101011 (1) - 10/11/2010; 101119 (1) - 11/19/2010; 120221 (4) - 02/21/2012; NOT PROVIDED (3). THE COMPLAINT BREATHING CIRCUITS ARE NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINLY BASED ON OUR KNOWLEDGE OF THE PRODUCT. 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 RT226, 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. A LOT CHECK HAS REAVELED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS PROVIDED ABOVE FOR THIS PRODUCT. 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 BEND THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    OUR DISTRIBUTOR IN (B)(6) REPORTED THAT VARIOUS HOSPITALS HAD FOUND THAT THE HEATER WIRE PINS OF THE INSPIRATORY BREATHING TUBE WERE DAMAGED ON THE RT226 INFANT LOW FLOW BREATHING CIRCUITS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT LOW FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT226 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1