BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2497735 · Received March 20, 2012

    Report

    Report Number
    9611451-2012-00160
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 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 K034026. METHOD: THE COMPLAINT RT265 INFANT BREATHING CIRCUIT HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND PERFORMANCE TESTED. RESISTANCE AND SURFACE TEMPERATURE MEASUREMENTS WERE PERFORMED ON THE INSPIRATORY AND EXPIRATORY LIMBS OF THE COMPLAINT DEVICE. RESULT: THE RESISTANCE AND SURFACE TEMPERATURE MEASUREMENTS OF THE INSPIRATORY AND EXPIRATORY LIMBS WERE WITHIN SPECIFICATIONS. THE HOSPITAL ALSO REPORTED THAT THE BREATHING TUBE WAS LYING DIRECTLY ON THE PATIENT'S LEG, WITHOUT BEING COVERED. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: WE WERE UNABLE TO CONFIRM THE REPORTED FAULT OF THE BREATHING CIRCUIT BECOMING VERY HOT. NO FAULT WAS FOUND ON THE RETURNED COMPLAINT DEVICE. THE REPORTED TEMPORARY REDDENING OF THE PATIENT'S THIGH WAS MOST LIKELY CAUSED BY PROLONGED CONTACT OF THE BREATHING TUBE WITH THE PATIENT'S LEG. THE USER INSTRUCTIONS PROVIDED WITH THE RT265 INFANT BREATHING CIRCUIT STATES: - "AVOID PROLONGED CONTACT WITH PATIENT'S SKIN." - "DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS BLANKETS, TOWELS OR BED LINEN."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT265 INFANT BREATHING CIRCUIT KIT BECAME VERY HOT AND CAUSED TEMPORARY REDDENING ON THE PATIENT'S THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1