BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1063700 · Received June 20, 2008

    Report

    Report Number
    9611451-2008-00290
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERRED TO IN THIS COMPLAINT IS NOT SOLD IN THE USA, BUT A SIMILAR PRODUCT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION. RESULTS: THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT CONNECTS TO ONE PORT OF THE WYE PIECE, THE EXPIRATORY TUBE TO THE OTHER. THIS IS DONE DURING PRODUCTION. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: A MISSING WYE PIECE WOULD HAVE BEEN DETECTED AT THREE SEPARATE POINTS DURING PRODUCTION: DURING PRESSURE TESTING WHEN THE WYE PIECE IS REQUIRED TO HOLD THE INSPIRATORY AND EXPIRATORY TUBES TOGETHER. AT THE WEIGHT STATIONS WHICH WOULD ALARM IF THE PACKAGE WAS TOO LIGHT. DURING PACKING WHERE THE CIRCUIT WOULD BE DIFFICULT TO PACK WITHOUT A WYE PIECE. WE CANNOT CONCLUDE THE WYE PIECE COULD HAVE BEEN MISSING. OUR MONITORING AND TRENDING FOR THIS TYPE OF COMPLAINT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.003%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT THE WYE PIECE WAS MISSING FROM AN RT340 ADULT BREATHING CIRCUIT WHEN THE PACKAGING WAS OPENED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD. RT340 080227

    Patients

    Seq Age Sex Outcome Treatment
    1