BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2893855 · Received January 2, 2013

    Report

    Report Number
    9611451-2013-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    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 COMPLAINT RT205 BREATHING CIRCUIT IS CURRENTLY IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT205 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE DEVICE WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED THE PRESSURE DROP TO BE OUTSIDE OF SPECIFICATION FOR THIS PRODUCT. THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AT THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP. CONCLUSION: THE LEAK WAS CAUSED BY A FAILURE IN THE SEAL BETWEEN THE WATER TRAP BOWL AND LID. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED POST PRODUCTION DURING TRANSPORT, STORAGE OR USE. THE USER INSTRUCTIONS FOR RT205 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARM."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT205 ADULT BREATHING CIRCUIT DID NOT PASS THE SERVO VENTILATOR LEAK TEST. IT WAS FOUND THE THE DEVICE WAS LEAKING AIR AT THE CONNECTION BETWEEN THE WATER TRAP BOWL AND THE LID. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT205 ADULT BREATHING CIRCUIT DID NOT PASS THE SERVO VENTILATOR LEAK TEST. IT WAS FOUND THE THE DEVICE WAS LEAKING AIR AT THE CONNECTION BETWEEN THE WATER TRAP BOWL AND THE LID. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT205 120827

    Patients

    Seq Age Sex Outcome Treatment
    1