BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1610127 · Received February 11, 2010

    Report

    Report Number
    9611451-2010-00059
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 7, 2010
    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 THE SIMILAR PRODUCT IS K983112. THE DEVICE IS CURRENTLY EN ROUTE TO THE MFR. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED THE DEVICE AND CARRIED OUT AN INVESTIGATION.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED VIA THEIR DISTRIBUTOR THAT AN RT200 ADULT BREATHING CIRCUIT LEAKED AS SOON AS THEY STARTED USING IT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200

    Patients

    Seq Age Sex Outcome Treatment
    1