BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3730091 · Received April 7, 2014

    Report

    Report Number
    9611451-2014-00304
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    January 23, 2013
    Report Date
    March 14, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    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 RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT 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 COMPLAINT RT105 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4)FOR INSPECTION. IT WAS VISUALLY INSPECTED, PRESSURE TESTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED THAT THE COMPLAINT CIRCUIT WAS OUT OF SPECIFICATION DUE TO AN EXCESSIVE LEAK. THE WATER BATH CONFIRMED THAT THE LEAK WAS AT THE CONNECTION BETWEEN THE LID AND BOWL OF THE INSPIRATORY WATER TRAP. A LOT CHECK REVEALED FOUR OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120625. 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 THE SUBJECT RT105 ADULT BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. USER INSTRUCTIONS THAT ACCOMPANY THE RT105 ADULT INSPIRATORY HEATED 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. THE HOSPITAL STAFF CORRECTLY CHECKED THE SUBJECT 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE A RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT FAILED THE SERVO-S LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206448 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 120625

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-S VENTILATOR