BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1584638 · Received January 20, 2010

    Report

    Report Number
    9611451-2010-00022
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    December 4, 2009
    Report Date
    January 11, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT 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. THE COMPLAINT BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVAL. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A LEAK WAS FOUND IN AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT. THE LEAK 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 090219

    Patients

    Seq Age Sex Outcome Treatment
    1