BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1052715 · Received May 23, 2008

    Report

    Report Number
    9611451-2008-00327
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT. CONCLUSION: IT IS LIKELY THAT IN THIS CASE, A HIGH FLOW INSPIRATORY TUBE (WITH SHORTER HEATERWIRE) WAS INCORRECTLY INCLUDED IN THE RT329 INFANT BREATHING CIRCUIT. THERE ARE 2 INFANT BREATHING CIRCUITS MANUFACTURED WITH TWO DIFFERENT HEATERWIRE LENGTHS. 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 PAST YEAR OF 0.0026%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO US THAT THE TEMPERATURE WIRE (I.E. HEATERWIRE) OF AN RT329 INFANT BREATHING CIRCUIT WAS APPROXIMATELY 10 - 15 CM AWAY FROM THE TEMPERATURE PROBE INSERT. 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. RT329

    Patients

    Seq Age Sex Outcome Treatment
    1