BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 1610126 · Received February 9, 2010

    Report

    Report Number
    9611451-2010-00053
    Event Type
    Malfunction
    Date Received
    February 9, 2010
    Date of Event
    December 25, 2009
    Report Date
    January 19, 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 RT105 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 ONE (1) OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 090210. 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 HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THEY RECEIVED AN RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT WAS NOT HEATING. THE HOSPITAL REPORTED THAT THE CIRCUIT WAS BEING USED IN A SET-UP WHICH INCLUDED A DRAGER EVITA VENTILATOR, WHICH SOUNDED A HEATER WIRE ALARM. THE HOSPITAL REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES ASSOCIATED WITH THE OPEN CIRCUIT HEATER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105 090210

    Patients

    Seq Age Sex Outcome Treatment
    1