BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1524184 · Received November 5, 2009

    Report

    Report Number
    9611451-2009-00588
    Event Type
    Malfunction
    Date Received
    November 5, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 7, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT 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. THE DEVICE IS STILL ON ITS WAY TO OUR FACILITY. WE WILL PROVIDE A FOLLOW UP REPORT ON OUR INVESTIGATION RESULTS ONCE WE RECEIVE THE DEVICE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA THEIR DISTRIBUTOR THAT AN RT206 ADULT BREATHING CIRCUIT DID NOT PASS THE LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT206 090220

    Patients

    Seq Age Sex Outcome Treatment
    1