BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-HEATED BREATHING CIRCUIT

    MDR report key: 1749521 · Received June 30, 2010

    Report

    Report Number
    9611451-2010-00411
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 30, 2010
    Report Date
    May 31, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE (B)(4) 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 K020332. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA A DISTRIBUTOR THAT A FIRE OCCURRED IN A SET-UP WHICH INCLUDED A BC060 SINGLE-HEATED BREATHING CIRCUIT, MR850 RESPIRATORY HUMIDIFIER, AND A MR290 HUMIDIFICATION CHAMBER DURING USE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. BC060

    Patients

    Seq Age Sex Outcome Treatment
    1 TEMPERATURE PROBE OF UNK MODEL| FISHER & PAYKEL HEALTHCARE MR850 REPIRATORY| MR290 HUMIDIFICATION CHAMBER| HEATER WIRE ADAPTOR| HUMIDIFIER