BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2589602 · Received May 28, 2012

    Report

    Report Number
    9611451-2012-00308
    Event Type
    Injury
    Date Received
    May 28, 2012
    Report Date
    April 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT124 INFANT CONTINOUS FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: TWO COMPLAINT BREATHING CIRCUITS WERE RETURNED TO THE MANUFACTURER. THE COMPLAINT BREATHING CIRCUITS WERE VISUALLY INSPECTED AND CONNECTED TO AN MR850 RESPIRATORY HUMIDIFIER AND PERFORMANCE TESTED OVER A PERIOD OF TWO DAYS (6 HOURS PER DAY) TO CHECK FOR CONDENSATION. A HEATER WIRE RESISTANCE TEST WAS ALSO PERFORMED USING A MULTIMETER. ATTEMPTS TO OBTAIN FURTHER DETAILED INFORMATION WITH REGARD TO THE SET UP, EVENT AND PATIENT HAS BEEN UNSUCCESSFUL. RESULTS: A VISUAL INSPECTION REVEALED NO DAMAGES TO BOTH OF THE RETURNED COMPLAINT BREATHING CIRCUITS. THE HEATER WIRE RESISTANCE TEST OF BOTH COMPLAINT BREATHING CIRCUITS WERE FOUND TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. WHEN THE BREATHING CIRCUITS WERE PERFORMANCE TESTED, NO CONDENSATION WAS OBSERVED IN THE INSPIRATORY LIMB OF BOTH BREATHING CIRCUITS. 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. NO FAULT WAS FOUND WITH THE TWO RETURNED COMPLAINT BREATHING CIRCUITS. WITHOUT FURTHER DETAILED INFORMATION, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. IT IS; HOWEVER, POSSIBLE THAT SET-UP AND ENVIRONMENTAL CONDITIONS MAY HAVE CONTRIBUTED TO THE PROBLEM. SHOULD WE RECEIVE ANY PERTINENT INFORMATION WITH REGARD TO THE EVENT, WE WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS CONDENSATION IN TWO RT124 INFANT CONTINUOUS FLOW BREATHING CIRCUITS DURING USE. THE HOSPITAL ALLEGED THAT THE PATIENT "ASPIRATED SOME CONDENSATE" AND REQUIRED RESUSCITATION, AND THAT THIS HAPPENED ON TWO SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT124 120222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FPH MR850 RESPIRATORY HUMIDIFIER| INCUBATOR