BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1232542 · Received November 13, 2008

    Report

    Report Number
    9611451-2008-00667
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Report Date
    October 14, 2008
    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

    THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE DEVICE IS CURRENTLY EN ROUTE TO THE MANUFACTURER FOR INSPECTION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN ANOTHER COUNTRY, REPORTED THAT BEFORE USE, THEY FOUND A QUANTITY OF 2 RT225 INFANT BREATHING CIRCUITS WITH LEAKS AT THE "Y" PIECE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 080723

    Patients

    Seq Age Sex Outcome Treatment
    1