BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1759378 · Received June 23, 2010

    Report

    Report Number
    9611451-2010-00391
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    May 31, 2010
    Report Date
    May 31, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL LOT NUMBERS, DATE OF MANUFACTURE: 090711, 07/11/2009, QUANTITY 1, 090921, 09/21/2009, QUANTITY 1, 100211, 02/11/2010, QUANTITY 1. 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: THE RETURNED BREATHING CIRCUITS WERE TESTED FOR BENT OR DAMAGED PINS. RESULTS: THE EXPIRATORY LIMB HEATER WIRE PINS ON THE BREATHING CIRCUIT WAS SPLIT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090505, 090711, 090921 OR 100211. 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. DAMAGED PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT FOUR RT200 ADULT DUAL HEATED BREATHING CIRCUITS HAD BENT EXPIRATORY HEATER WIRE PINS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 090505

    Patients

    Seq Age Sex Outcome Treatment
    1