BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3371971 · Received September 26, 2013

    Report

    Report Number
    9611451-2013-00729
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    September 2, 2013
    Report Date
    September 2, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE RT205 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: THREE RT205 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED, PRESSURE TESTED, AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULTS WERE OUTSIDE OF THE SPECIFICATION DUE TO EXCESSIVE LEAK. WHEN THE SUBJECT BREATHING CIRCUITS WERE IMMERSED IN THE WATER BATH, THE LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE LID AND THE BOWL OF THE WATER TRAP. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 130419. 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 RT205 ADULT BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT TWO RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. FURTHER INSPECTION REVEALED THAT THE LEAK WAS COMING FROM THE EXPIRATORY LIMBS. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486536 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT205 130419

    Patients

    Seq Age Sex Outcome Treatment
    1