BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1170679 · Received September 16, 2008

    Report

    Report Number
    9611451-2008-00538
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 12, 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

    ELECTRICAL TESTS WERE PERFORMED ON THE HEATERWIRE OF THE RETURNED BREATHING CIRCUIT. RESULTS: THE HEATERWIRE IN THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT WAS AN ELECTRICAL OPEN CIRCUIT. ELECTRICAL TESTING INDICATED A BROKEN CONNECTION BETWEEN THE HEATERWIRE AND ONE OF THE HEATERWIRE PINS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. 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. OUR MONITORING AND TRENDING OF OPEN CIRCUITS ON ADULT HEATED BREATHING CIRCUIT HEATERWIRES HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST YEAR TO THE END OF AUGUST 2008 OF 0.0025 %.

    Description of Event or Problem · 1

    REPORTER REPORTED VIA OUR DISTRIBUTOR THAT THE EXPIRATORY PORT OF AN RT100 ADULT BREATHING CIRCUIT WAS DEFECTIVE. 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. RT100 080524

    Patients

    Seq Age Sex Outcome Treatment
    1