BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1610325 · Received February 15, 2010

    Report

    Report Number
    9611451-2010-00049
    Event Type
    Malfunction
    Date Received
    February 15, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 6, 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 WIRE IN THE INSPIRATORY TUBE OF THE RETURNED BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE IS OPEN CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090727. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE TIMING OF USE SHOWS THAT THE HEATER WIRE BECAME AN OPEN CIRCUIT POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT204 ADULT DUAL HEATED BREATHING CIRCUIT BECAME OPEN CIRCUIT AFTER ONE HOUR OF 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 090727

    Patients

    Seq Age Sex Outcome Treatment
    1