BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1869949 · Received October 14, 2010

    Report

    Report Number
    9611451-2010-00625
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 17, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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 K983112. METHOD: TWO COMPLAINT BREATHING CIRCUITS WERE RECEIVED. ONE HAD LOT NUMBER 100325 AND THE SECOND WAS 100108. THE PINS ON THE INSPIRATORY AND EXPIRATORY LIMB OF BOTH COMPLAINT BREATHING CIRCUITS WERE TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS NOT POSSIBLE FOR BOTH THE INSPIRATORY AND EXPIRATORY LIMBS OF THE BREATHING CIRCUIT WITH LOT NUMBER 100325. THE PINS OF THE EXPIRATORY LIMB WERE FOUND TO BE BENT AND THE PINS ON THE INSPIRATORY LIMB WERE BENT AND SPLIT. THE PINS ON THE INSPIRATORY LIMB OF BREATHING CIRCUIT, LOT 100108, WERE BENT AND FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS NOT POSSIBLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBERS. 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 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

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT200 ADULT DUAL HEATED BREATHING CIRCUITS WERE FOUND TO HAVE "DEFECTIVE PINS" ON THE EXPIRATORY LIMB DURING SET UP. 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 RT200 100325, 100108

    Patients

    Seq Age Sex Outcome Treatment
    1