BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-HEATED ADULT BREATHING CIRCUIT

    MDR report key: 3903848 · Received June 30, 2014

    Report

    Report Number
    9611451-2014-00569
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FOUR COMPLAINT RT134 BREATHING CIRCUITS WERE VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: PRESSURE TESTING REVEALED THAT THE CIRCUITS WERE OUT OF SPECIFICATION. THE WATER BATH TEST REVEALED LEAKS BETWEEN THE WATER TRAP BOWLS AND THE LIDS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 130514 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 CONDENSATE. 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 CUSTOMER HAD COMMENTED THAT THE COMPLAINT CIRCUITS PASSED THE VENTILATOR LEAK TEST WHICH SUGGESTS THAT THE WATER TRAPS BECAME LOOSE DURING SETUP OF THE DEVICES. 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT FOUR RT134 ADULT BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO-I VENTILATOR. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380109 NON-HEATED ADULT BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT134 130514

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR