BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2380205 · Received December 18, 2011

    Report

    Report Number
    9611451-2011-00794
    Event Type
    Malfunction
    Date Received
    December 18, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT104 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT104 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT BE FULLY CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE AS ONE OF THE HEATER WIRE PINS WAS FOUND TO BE SPLIT. THIS PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET. A LOT CHECK REVEALED NO OTHER TYPE OF THIS COMPLAINT FOR LOT 110727. 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 A DISTRIBUTOR THAT THE HEATER WIRE ADAPTOR COULD NOT CONNECT TO AN RT104 ADULT BREATHING CIRCUIT AS THE HEATER WIRE PINS WERE BENT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT104 110727

    Patients

    Seq Age Sex Outcome Treatment
    1