BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 2600209 · Received June 6, 2012

    Report

    Report Number
    9611451-2012-00369
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 7, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER: (B)(4). LOT NUMBER: 120216, 120307. DEVICE MANUFACTURER DATE: 02/16/2012, 03/07/2012. METHOD: ONE COMPLAINT BREATHING CIRCUIT , LOT 120307, WAS RETURNED TO THE MANUFACTURER. THE COMPLAINT BREATHING CIRCUIT WAS RECEIVED IN A SEALED HAZARDOUS BAG. THE BAG WAS NOT OPENED DUE TO THE POTENTIALLY HAZARDOUS CONTAMINATION. THE COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION OF THE BREATHING CIRCUIT REVEALED NO VISIBLE DAMAGE TO THE COMPLAINT BREATHING CIRCUIT. FLUID WAS OBSERVED IN THE SEALED IN BAG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120216. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120307. CONCLUSION: CONDENSATE IN THE HUMIDIFICATION SYSTEM, ALTHOUGH NOT PREFERRED, IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THE AMOUNT OF CONDENSATE IN THE VENTILATION SYSTEM IS INFLUENCED BY MULTIPLE SETUP AND ENVIRONMENTAL FACTORS. COLD AIR SOURCES SUCH AS FANS, OPEN WINDOWS AND AIR CONDITIONING CAN CAUSE WARM HUMIDITY IN THE TUBE TO CONDENSE. WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. HOWEVER, THE HOSPITAL HAS INFORMED US THAT FANS ARE FREQUENTLY USED IN THE PATIENT'S ROOMS. IT IS POSSIBLE THAT THE OBSERVED CONDENSATION WAS DUE TO ENVIRONMENTAL FACTORS, SUCH AS THE USE OF A FAN. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS VISITED THIS HOSPITAL SINCE THE COMPLAINT WAS RECEIVED TO ENSURE THAT THEY SET-UP THEIR SYSTEM PROPERLY AND TO ELIMINATE ANY ENVIRONMENTAL FACTORS THAT MAY CONTRIBUTE TO CONDENSATE IN THE SYSTEM.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THEY WERE EXPERIENCING CONDENSATION IN THE EXPIRATORY LIMB OF RT210 ADULT DUAL-HEATED BREATHING CIRCUITS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THEY WERE EXPERIENCING CONDENSATION IN THE EXPIRATORY LIMB OF RT210 ADULT DUAL-HEATED BREATHING CIRCUITS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT210

    Patients

    Seq Age Sex Outcome Treatment
    1