BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1565037 · Received November 17, 2009

    Report

    Report Number
    9611451-2009-00653
    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): ADD'L LOT NUMBERS: 090524, 080404. ADD'L DEVICE MFR DATES: 05/24/2009, 04/04/2009. 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 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 IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT THE HEATER WIRE ALARM WAS TRIGGERED ON THE RESPIRATORY HUMIDIFIER WHILE IN CONNECTION WITH A RT212 ADULT BREATHING CIRCUIT. THIS PROBLEM WAS REPORTED TO HAVE OCCURRED WITH THREE RT212 BREATHING CIRCUITS. 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 090324

    Patients

    Seq Age Sex Outcome Treatment
    1