BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4130997 · Received September 30, 2014

    Report

    Report Number
    9611451-2014-00788
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    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). THE RT345 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT345 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED, PRESSURE TESTED AND IMMERSED IN A WATER BATH TO FIND THE SOURCE OF THE LEAK. RESULTS: VISUAL INSPECTION REVEALED THAT THE EVAQUA (EXPIRATORY) LIMB PROXIMAL CONNECTOR WAS INCORRECTLY ASSEMBLED. THE PRESSURE TEST SHOWED THAT THE CIRCUIT WAS OUT OF SPECIFICATION. THE WATER BATH TEST CONFIRMED THAT THE PROXIMAL CONNECTOR ON THE EXPIRATORY LIMB WAS THE SOURCE OF THE LEAK. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE RELEASING FOR DISTRIBUTION, AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS SUPPLIED WITH ADULT EVAQUA 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 VIA OUR DISTRIBUTOR THAT AN RT345 ADULT BREATHING CIRCUIT FAILED THE SERVO VENTILATOR LEAK TEST BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608894 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT345

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO VENTILATOR