BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT UNHEATED BREATHING CIRCUIT

    MDR report key: 3151048 · Received June 6, 2013

    Report

    Report Number
    9611451-2013-00448
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 10, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT134 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED, PRESSURE TESTED TO SPECIFICATION, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT WAS OUTSIDE OF THE SPECIFICATION DUE TO EXCESSIVE LEAK IN THE WATER TRAP. THE LEAK WAS CONFIRMED WHEN THE WATER TRAP WAS IMMERSED IN A WATER BATH. A LOT CHECK WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER RELEASE FOR DISTRIBUTION, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT134 ADULT UNHEATED BREATHING CIRCUIT 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 PATIENT." "SET APPROPRIATE ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT134 ADULT UNHEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250521 ADULT UNHEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT134 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1