BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2749541 · Received September 18, 2012

    Report

    Report Number
    9611451-2012-00644
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    July 27, 2012
    Report Date
    August 22, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE DESCRIPTION OF THE PROBLEM AND OUR KNOWLEDGE OF THE PRODUCT. THE THREE COMPLAINT BREATHING CIRCUITS WERE FROM LOTS 120404, 120425 AND 120523 (MANUFACTURED ON 4 APRIL 2012, 25 APRIL 2012 AND 23 MAY 2012 RESPECTIVELY). 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 INSPIRATORY TUBE OF THE RT340, 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 REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE THREE 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 BEND OR SPLIT THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT OR SPLIT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THEY WERE UNABLE TO CONNECT THE HEATER WIRE ADAPTOR TO THE INSPIRATORY LIMB OF THREE RT340 BREATHING CIRCUITS BECAUSE THE HEATER WIRE PINS WERE DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120404

    Patients

    Seq Age Sex Outcome Treatment
    1