BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO

    MDR report key: 2132087 · Received June 16, 2011

    Report

    Report Number
    9611451-2011-00363
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 20, 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). THE RT127 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE SLE RESTRICTOR IS INSERTED INTO THE BREATHING CIRCUIT DURING PRODUCTION TO RESTRICT FLOW WHEN USED WITH THE SLE VENTILATOR. THERE WAS A CRACK IN THE SLE RESTRICTOR ALONG THE FLOW LINE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: ALL FISHER & PAYKEL HEALTHCARE BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS. THIS SUGGESTS THAT THE CRACK DEVELOPED POST-PRODUCTION. IT IS LIKELY THAT THERE WAS A MOULDING DEFECT IN THE RESTRICTOR WHICH THEN CRACKED WHEN THE CONNECTORS WERE TIGHTENED DURING SET-UP. OUR MONITORING AND TRENDING REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THE PAST 12 MONTHS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS A CRACK IN THE RED RESTRICTOR OF AN RT127 INFANT BREATHING CIRCUIT. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT127 101116

    Patients

    Seq Age Sex Outcome Treatment
    1