BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1699064 · Received May 21, 2010

    Report

    Report Number
    9611451-2010-00295
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 10, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. THE COMPLAINT BREATHING CIRCUIT WAS TESTED FOR DAMAGED HEATER WIRE PINS. RESULTS: AN EXPIRATORY HEATER WIRE PIN WAS FOUND TO BE BROKEN AND SPLIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091022. 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 HEALTH CARE 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 PT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT HEATER WIRE SOCKET WAS BENT. THE REPORTED FAULT WAS DISCOVERED PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD. RT340 091022

    Patients

    Seq Age Sex Outcome Treatment
    1