BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 3150981 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00455
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT330 INFANT OPTIFLOW CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, PREVIOUS INVESTIGATIONS OF SIMILAR COMPLIANTS AND OUR KNOWLEDGE OF THE PRODUCT. A LOT CHECK COULD NOT BE PEFORMED AS A LOT NUMBER WAS NOT PROVIDED. WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM EXPERIENCED BY THE CUSTOMER. HOWEVER, IT IS POSSIBLE THAT THE OBSERVED CONDENSATE WAS INFLUENCED BY ENVIRONMENTAL CONDITIONS, SUCH AS THE AMBIENT TEMPERATURE. 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 A NUMBER OF MULTIPLE SET UP AND ENVIRONMENTAL FACTORS. SINCE THE REPORTED COMPLAINT AN FPH REPRESENTATIVE HAS BEEN IN DAILY COMMUNICATION WITH THE HOSPITAL STAFF AND IS WORKING WITH THEM TO RESOLVE ANY FURTHER CONDENSATION ISSUES. FURTHERMORE, THE HOSPITAL STAFF HAVE REPORTED TO THE REP THAT THEY HAVE HAD NO FURTHER ISSUES. THE USER INSTRUCTIONS SUPPLIED WITH THE RT330 INFANT OPTIFLOW CIRCUIT STATE THE FOLLOWING: "PATIENT MONITORING IS RECOMMENDED" "DO NOT COVER THE CIRCUIT WITH MATERIAL SUCH AS BLANKETS, TOWELS OR BED LINEN."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED VIA OUR DISTRIBUTOR THAT THEY NOTICED EXCESSIVE CONDENSATION IN THE RT330 INFANT OPTIFLOW CIRCUIT DURING USE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249732 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT330 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1