BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2552458 · Received April 29, 2012

    Report

    Report Number
    9611451-2012-00266
    Event Type
    Malfunction
    Date Received
    April 29, 2012
    Date of Event
    March 16, 2012
    Report Date
    April 4, 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 RT205 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 RT205 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN NEW ZEALAND FOR INSPECTION AND PRESSURE TEST TO CHECK FOR LEAKS. RESULTS: PRESSURE TEST REVEALED THAT THE COMPLAINT DEVICE WAS ABLE TO PERFORM WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 102358. CONCLUSION: WE WERE NOT ABLE TO CONFIRM THE REPORTED FAULT AS NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT DEVICE. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA AN FPH FIELD REPRESENTATIVE THAT AN AIR LEAK WAS FOUND ON THE WATER RAP OF AN RT205 ADULT BREATHING CIRCUIT, WHICH FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT205 111108

    Patients

    Seq Age Sex Outcome Treatment
    1