BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1172089 · Received September 18, 2008

    Report

    Report Number
    9611451-2008-00540
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 20, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR BENT PINS AND TESTED TO SEE IF IT SHOULD BE CONNECTED TO A HEATERWIRE ADAPTOR. RESULTS: A HEATERWIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATERWIRE SOCKET IN THE INSPIRATORY LIMB. A VISUAL INSPECTION REVEALED THAT ONE OF THE HEATERWIRE PINS INSIDE THE HEATERWIRE SOCKET WAS SPLIT AT THE TOP. THIS SPLIT PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATERWIRE SOCKET. WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT. CONCLUSION: AN IMPROVEMENT WAS MADE TO THE PRODUCTION PROCESS TO PREVENT BENT PINS PASSING THE PRODUCTION TEST. AS NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT, WE WERE UNABLE TO ASCERTAIN WHETHER THIS CIRCUIT WAS MADE BEFORE OR AFTER THIS IMPROVEMENT WAS EFFECTIVE. OUR MONITORING AND TRENDING OF BENT PINS ON HEATED BREATHING CIRCUITS HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR TO THE END OF AUGUST 2008 OF 0.0012%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT THE HEATERWIRE PIN OF AN ADULT BREATHING CIRCUIT WAS BENT. 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. RT104

    Patients

    Seq Age Sex Outcome Treatment
    1