BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1133404 · Received August 22, 2008

    Report

    Report Number
    9611451-2008-00495
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR BENT PINS IN THE HEATERWIRE CONNECTION. RESULTS: ONE OF THE PINS IN THE HEATERWIRE CONNECTION OF THE EXPIRATORY TUBE WAS BENT. WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT. CONCLUSION: AN IMPROVEMENT WAS MADE TO THE PRODUCTION PROCESS TO PREVENT BENT PINS PASSING THE PRODUCTION TEST. WE WERE UNABLE TO ESTABLISH WHETHER THIS BREATHING CIRCUIT WAS MANUFACTURED BEFORE OR AFTER THIS IMPROVEMENT BECAME EFFECTIVE, AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT. OUR MONITORING AND TRENDING OF BENT PINS ON HEATED BREATHING CIRCUITS WORLDWIDE FOR THE LAST YEAR TO THE END OF 2008, HAS A RATE OF OCCURRENCE OF 0.0015 %.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED VIA OUR DISTRIBUTOR THAT AN RT340 ADULT BREATHING CIRCUIT COULD NOT BE HEATED. OUR DISTRIBUTOR FURTHER REPORTED THAT ONE PIN IN THE HEATERWIRE CONNECTION WAS BENT, AND IT COULD NOT BE CONNECTED PROPERLY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1