BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3982385 · Received August 6, 2014

    Report

    Report Number
    9611451-2014-00660
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 DUAL HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: PRESSURE TEST REVEALED THAT THE RETURNED CIRCUIT EXHIBITED LEAK AND WAS OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS THROUGH THE DISTAL CONNECTOR ON THE INSPIRATORY LIMB. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED LEAK. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE OBSERVED LEAK ONLY DEVELOPED AFTER THE BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "SET APPROPRIATE VENTILATOR ALARMS." THE HOSPITAL STAFF CORRECTLY CHECKED THE CIRCUIT PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE LEAK TEST ON A PURITAN BENNETT 840 AND T-BIRD VENTILATORS PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461861 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 140117

    Patients

    Seq Age Sex Outcome Treatment
    1 PURITAN BENNETT 840 VENTILATOR| T-BIRD VENTILATOR