BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3359083 · Received September 19, 2013

    Report

    Report Number
    9611451-2013-00704
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 23, 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 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(6) FOR EVALUATION. THE COMPLAINT CIRCUIT WAS PRESSURE TESTED TO OUR PRODUCT SPECIFICATION AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST IDENTIFIED A LEAK AND THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AT THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 130515. CONCLUSION: THE RT105 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 THAT THE LEAK DEVELOPED AFTER THE COMPLAINT DEVICE WAS RELEASED FOR DISTRIBUTION. THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAK DURING THE LEAK TEST, PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT105 ADULT BREATHING CIRCUIT FAILED A VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472646 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 130515

    Patients

    Seq Age Sex Outcome Treatment
    1