BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1920703 · Received October 28, 2010

    Report

    Report Number
    9611451-2010-00648
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 4, 2010
    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

    (B)(4). METHOD: THE RETURNED RT134 ADULT BREATHING CIRCUIT WAS PRESSURE TESTED FOR LEAKS AND SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF TWO PARTS WHERE THE BOWL CAN BE REMOVED DURING USE FOR DRAINING CONDENSATE. INVESTIGATION REVEALED A LEAK IN THE SEAL BETWEEN THE BOWL AND THE LID OF THE EXPIRATORY WATER TRAP. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBER 091218. CONCLUSION: A LEAK IN A WATER TRAP OF THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAKS MUST HAVE DEVELOPED POST PRODUCTION. THE USER INSTRUCTIONS FOR RT134 STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PT. SET APPROPRIATE VENTILATOR ALARMS. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT134 ADULT BREATHING CIRCUIT LEAKED FROM THE WATER TRAP. THIS WAS OBSERVED SHORTLY AFTER IT WAS USED ON A PT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT134 091218

    Patients

    Seq Age Sex Outcome Treatment
    1