BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT KIT

    MDR report key: 2240157 · Received September 9, 2011

    Report

    Report Number
    9611451-2011-00554
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 16, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO CHECK FOR LEAKS. THE INFANT BREATHING CIRCUIT FAILED THE PRESSURE TEST. UPON SUBMERSION IN A WATER BATH, THE LEAK WAS DETECTED AROUND THE SWIVEL Y-PIECE. A STRONG FORMATION OF BUBBLES WERE NOTICED AROUND THE SWIVEL. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100510. THE LEAK WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE SWIVEL Y-PIECE THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT226 INFANT BREATHING CIRCUIT FAILED THE LEAK TEST ON A SERVO-S VENTILATOR. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT LOW FLOW BREATHING CIRCUIT KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT226 100510

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-S VENTILATOR