BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1070451 · Received July 7, 2008

    Report

    Report Number
    9611451-2008-00417
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 13, 2006
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT212 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO ANOTHER DEVICE WHICH IS SOLD IN THE USA. ONLY THE INSPIRATORY TUBE OF THE COMPLAINT DEVICE WAS RETURNED. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE RETURNED COMPLAINT DEVICE DID NOT PASS THE LEAK TEST. A SMALL MOLDING FLAW IN THE INSPIRATORY TUBE WAS FOUND, CAUSING THE LEAK TO OCCUR. CONCLUSION: THE REPORTED FAULT WAS CONFIRMED AND WAS DUE TO A SMALL LEAK IN THE INSPIRATORY TUBE, WHICH HAS BEEN CAUSED BY A MOLDING FLAW. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE LEAK FROM THE MOLDING FLOW BECAME WORSE WHEN THE CIRCUIT WAS USED. OUR MONITORING AND TRENDING FOR LEAKING ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0041%.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT A LEAK WAS FOUND IN AN RT212 ADULT BREATHING CIRCUIT DURING CIRCUIT LEAK TEST. THIS WAS FOUND PRIOR TO USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT212 080110

    Patients

    Seq Age Sex Outcome Treatment
    1