BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1053653 · Received May 27, 2008

    Report

    Report Number
    9611451-2008-00332
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    April 30, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERRED IN THIS COMPLAINT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE DEVICE IS EN ROUTE TO THE MFR FOR INSPECTION. WE HAVE AN OPEN CAPA ITEM TO ADDRESS SUCH COMPLAINTS AND TO PUT MEASURES IN PLACE TO REDUCE AND/OR PREVENT RECURRENCE. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST YEAR OF 0.0026%.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN ANOTHER COUNTRY, REPORTED THAT THE WRONG CONNECTOR WAS SUPPLIED WITH AN RT226 INFANT BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT226 080408

    Patients

    Seq Age Sex Outcome Treatment
    1