BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1641056 · Received March 23, 2010

    Report

    Report Number
    9611451-2010-00172
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 18, 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 PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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 RT100 BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: THE INSPIRATORY HEATER WIRE WAS AN OPEN LOOP DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090910. 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 THE 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 OUR DISTRIBUTOR THAT A RT100 ADULT BREATHING CIRCUIT ACTIVATED THE HEATER WIRE ALARM DURING USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT100 090910

    Patients

    Seq Age Sex Outcome Treatment
    1