BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1841250 · Received September 14, 2010

    Report

    Report Number
    9611451-2010-00554
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    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

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510 (K) NUMBER OF THAT PRODUCT IS K20332. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED. RESULTS: A SMALLER ADAPTOR WAS FOUND TO BE LODGED IN ONE OF THE LARGER ADAPTORS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE ACCESSORY BAG OF THE RT225 BREATHING CIRCUIT KIT CONTAINS A NUMBER OF ADAPTERS AND CONNECTORS. IT IS LIKELY THAT MOVEMENT DURING TRANSPORT OR STORAGE COULD HAVE CAUSED ONE OF THESE COMPONENTS TO SLIDE INTO ANOTHER COMPONENT AND BECOME STUCK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN ADDITIONAL TUBE HAD BEEN INSERTED INTO AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT ADAPTOR, MAKING IT UNUSABLE. THIS WAS OBSERVED PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 100324

    Patients

    Seq Age Sex Outcome Treatment
    1