BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2420860 · Received January 18, 2012

    Report

    Report Number
    9611451-2012-00028
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 28, 2011
    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 RT212 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: THE COMPLAINT RT212 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR INSPECTION AND PERFORMANCE TESTED TO CHECK FOR LEAKS. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 110927. RESULTS: THE PRESSURE TEST REVEALED THAT THE COMPLAINT DEVICE WAS ABLE TO PERFORM WITHIN THE PRODUCTION SPECIFICATION AND NO FAULT WAS FOUND WITH THE DEVICE. CONCLUSION: WE WERE UNABLE TO REPLICATE THE REPORTED FAULT AS NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS FOR RT212 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 RT212 ADULT BREATHING CIRCUIT WAS FOUND TO BE LEAKING AIR DURING VENTILATOR TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT212 110927

    Patients

    Seq Age Sex Outcome Treatment
    1