BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-HEATED ADULT BREATHING CIRCUIT

    MDR report key: 3903952 · Received June 30, 2014

    Report

    Report Number
    9611451-2014-00581
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT RT134 BREATHING CIRCUIT WAS VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH TO CHECK FOR LEAK. RESULTS: PRESSURE TESTING REVEALED THAT THE CIRCUIT WAS OUT OF SPECIFICATION. THE WATER BATH TEST REVEALED THAT THE LEAK WAS IN THE EXPIRATORY WATER TRAP. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 130923. CONCLUSION: THE WATER TRAP OF THE BREATHING CIRCUIT CONSISTS OF TWO PARTS, A LID AND A BOWL, WHICH CAN BE DISCONNECTED DURING USE FOR DRAINING WATER. THE WATER TRAP LEAK WAS LOCATED AT THE SEAL BETWEEN THE WATER TRAP BOWL AND THE WATER TRAP LID. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED POST PRODUCTION DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT134 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. SET APPROPRIATE VENTILATOR ALARMS. HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT134 ADULT BREATHING CIRCUIT FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379825 NON-HEATED ADULT BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT134 130923

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR