BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1172325 · Received September 19, 2008

    Report

    Report Number
    9611451-2008-00547
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 22, 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 510(K) FOR THAT PRODUCT IS K020332. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULT: A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: THE COMPONENT WAS MOST LIKELY OMITTED DURING OUR PACKING PROCESS. OUR RECORDS INDICATE THAT NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FOR THIS LOT NUMBER. OUR MONITORING AND TRENDING FOR MISSING OR WRONG COMPONENTS ON BREATHING CIRCUITS SHOWS A RATE OF OCCURRENCE OF WORLDWIDE FOR THE LAST YEAR.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY, REPORTED THAT AN RT225 INFANT BREATHING CIRCUIT WAS SUPPLIED WITHOUT THE ADAPTORS NORMALLY SUPPLIED. 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 080303

    Patients

    Seq Age Sex Outcome Treatment
    1