BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1170678 · Received September 16, 2008

    Report

    Report Number
    9611451-2008-00537
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE RETURNED DEVICE WAS VISUALLY INSPECTED FOR INCORRECT HEATERWIRE PLUGS. RESULTS: BREATHING CIRCUITS WITH HEATED INSPIRATORY AND EXPIRATORY TUBES HAVE DIFFERENT HEATERWIRE PLUGS FOR THE INSPIRATORY AND EXPIRATORY TUBES. DURING VISUAL INSPECTION THE INSPIRATORY TUBE WAS OBSERVED TO INCORRECTLY HAVE AN EXPIRATORY CONNECTOR. A LOT CHECK REVEALED 6 OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: AN INSPIRATORY TUBE WAS INCORRECTLY OVERMOLDED WITH AN EXPIRATORY PLUG DURING PRODUCTION. AN INVESTIGATION INTO THE PRODUCTION PROCESS REVEALED THAT THE OPERATOR MADE AN ERROR DURING PRODUCTION FOR APPROXIMATELY 2 HOURS. THE SIZE OF THE BATCH PRODUCED WAS NOT SIGNIFICANT. THE INCORRECT CIRCUIT PRODUCED CANNOT BE CONNECTED TO THE HUMIDIFIER. THIS IS EQUIVALENT TO AN OPEN CIRCUIT HEATERWIRE AND THE HUMIDIFIER WOULD ALARM, IN ADDITION TO THE USER DETECTING THIS ON SETUP. WE ARE CURRENTLY MODIFYING OUR PRODUCTION PROCESS TO REDUCE OR PREVENT RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT THE SHAPE OF THE HEATERWIRE ADAPTOR OF AN RT127 INFANT BREATHING CIRCUIT WAS DIFFERENT AND COULD NOT CONNECT. 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. RT127 080409

    Patients

    Seq Age Sex Outcome Treatment
    1