BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1882654 · Received October 18, 2010

    Report

    Report Number
    9611451-2010-00628
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT204 BREATHING CIRCUIT 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 ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE RETURNED RT204 ADULT DUAL-HEATED BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: NO FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUIT. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES WAS WITHIN THE REQUIRED SPECIFICATION. CONCLUSION: ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE RETURNED BREATHING CIRCUIT OPERATED CORRECTLY DURING TESTING AND THE REPORTED FAULT COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE RESISTANCE OF THE EXPIRATORY HEATER WIRE OF AN RT204 ADULT DUAL-HEATED BREATHING CIRCUIT WAS HIGH. THIS WAS NOTICED BEFORE PT USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT204 100129

    Patients

    Seq Age Sex Outcome Treatment
    1