BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3885079 · Received June 19, 2014

    Report

    Report Number
    9611451-2014-00539
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE RT206 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE BREATHING CIRCUIT WAS PRESSURE TESTED TO OUR PRODUCT SPECIFICATION TO CHECK FOR ANY LEAKS AND SUBMERGED IN A WATER BATH TO CHECK FOR THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE CIRCUIT WAS PERFORMING OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS AT THE CONNECTION BETWEEN THE LID AND THE BOWL OF THE WATER TRAP. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE RT206 BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID. THE WATER TRAP BOWL AND LID CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE CUSTOMER HAD CORRECTLY CHECKED THE BREATHING CIRCUITS FOR LEAK BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS. THE USER INSTRUCTIONS FOR RT206 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. - SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT206 ADULT BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST ON A PB840 VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361311 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR