BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2912656 · Received January 13, 2013

    Report

    Report Number
    9611451-2013-00035
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS PRESSURE TESTED AND IMMERSED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST RESULT WAS OUTSIDE OF THE SPECIFICATION DUE TO EXCESSIVE LEAK IN THE EXPIRATORY WATER TRAP. THE WATER TRAP OF THE BREATHING CIRCUIT CONSISTS OF TWO PARTS WHERE THE LOWER PART CAN BE REMOVED DURING USE FOR DRAINING WATER. THE WATER TRAP LEAK WAS LOCATED AT THE SEAL BETWEEN THE WATER TRAP BOWL AND THE WATER TRAP LID. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120625. CONCLUSION: 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, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE 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 VENTILATOR ALARMS." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. THE COMPLAINT ADULT BREATHING CIRCUIT IS EN ROUTE TO FPH FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19472 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT105 120625

    Patients

    Seq Age Sex Outcome Treatment
    1