BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2925915 · Received January 22, 2013

    Report

    Report Number
    9611451-2013-00059
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 2, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 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 K983112. METHOD: THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION IDENTIFIED THE PORT CAP TO BE MISSING FROM THE Y-PIECE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE MISSING PORT CAP. ALL CONNECTIONS ARE CHECKED BEFORE THE BREATHING CIRCUITS ARE PACKAGED. MOREOVER, ALL RT206 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IF THE PORT CAP HAD BEEN MISSING, THE COMPLAINT BREATHING CIRCUIT WOULD NOT HAVE PASSED THE LEAK TEST. THIS SUGGESTS THAT IS POSSIBLE THAT THE PORT CAP BECAME LOOSE POST PRODUCTION, POSSIBLE DURING TRANSPORTATION OR STORAGE. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF THIS NATURE FOR THIS PRODUCT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE "EXPIRATION LIMB PORT" OF AN RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS "DAMAGED". THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30299 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 120210

    Patients

    Seq Age Sex Outcome Treatment
    1