BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1220362 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00643
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 1, 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. ELECTRICAL TESTS WERE PERFORMED ON THE RETURNED DEVICE. RESULTS: THE HEATERWIRE IN THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT WAS AN ELECTRICAL OPEN CIRCUIT. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATERWIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATERWIRE BECAME AN OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. CHANGES HAVE BEEN MADE TO THE CRIMPING PROCESS WITH THE REPLACEMENT OF ALL CRIMPING MACHINES ON THE PRODUCTION LINE IN NOVEMBER 2007. AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT, WE ARE UNABLE TO ASCERTAIN WHETHER THIS PRODUCT WAS MANUFACTURED BEFORE OR AFTER THESE CHANGES BECAME EFFECTIVE. OUR MONITORING AND TRENDING FOR OPEN CIRCUIT HEATERWIRES ON ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR TO THE END OF SEPTEMBER 2008 OF 24 PPM.

    Description of Event or Problem · 1

    ANOTHER COUNTRY'S REPORTER REPORTED VIA OUR DISTRIBUTOR THAT THE HEATERWIRE OF AN RT106 ADULT BREATHING CIRCUIT BECAME AN OPEN CIRCUIT AFTER 3 HOURS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT106

    Patients

    Seq Age Sex Outcome Treatment
    1