BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1172085 · Received September 18, 2008

    Report

    Report Number
    9611451-2008-00542
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    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. METHOD: THE DEVICE WAS NOT RETURNED TO THE MFR FOR INSPECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE WITH SIMILAR COMPLAINTS. RESULTS: 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 OF MISSING OR WRONG COMPONENTS IN BREATHING CIRCUITS IS WORLDWIDE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT AN RT225 INFANT BREATHING CIRCUIT KIT WAS SUPPLIED WITHOUT THE CONNECTORS NORMALLY SUPPLIED. 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. RT225 080303

    Patients

    Seq Age Sex Outcome Treatment
    1