BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1565028 · Received November 17, 2009

    Report

    Report Number
    9611451-2009-00689
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    September 25, 2009
    Report Date
    November 20, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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. ADD'L LOT #S: 081121, 090416. ADD'L DEVICE MFR DATES: 11/21/2008, 04/16/2009. THE THREE RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A F/U REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY (B)(6) REPORTED TO OUR DISTRIBUTOR THAT THEY FOUND A FAULT ON THREE OF THE INSPIRATION HEATER WIRE CONNECTORS. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT212 081105

    Patients

    Seq Age Sex Outcome Treatment
    1