BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE-HEATED BREATHING CIRCUIT

    MDR report key: 1576687 · Received January 11, 2010

    Report

    Report Number
    9611451-2010-00003
    Event Type
    Other
    Date Received
    January 11, 2010
    Report Date
    December 8, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC060 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. FISHER & PAYKEL HEALTHCARE HAS REQUESTED THE URGENT RETURN OF THE MEDICAL DEVICES AND ACCESSORIES ASSOCIATED WITH THIS INCIDENT TO COMMENCE OUR ROOT CAUSE INVESTIGATION. IN ORDER TO FURTHER ASSIST IN OUR ANALYSIS, WE HAVE ALSO MADE FURTHER INQUIRY IN RESPECT OF THE CIRCUMSTANCES SURROUNDING THE EVENT, EQUIPMENT SET-UP AND USAGE. WE ARE STILL COLLATING RELEVANT INFORMATION AT THIS STAGE OF OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT OUTLINING OUR ANALYSIS OF THE INCIDENT FOLLOWING RECEIPT OF THE DEVICES AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT A FIRE OCCURRED IN A SET-UP WHICH INCLUDED THE BC060 SINGLE-HEATED BREATHING CIRCUIT, MR850 RESPIRATORY HUMIDIFIER, MR209 HUMIDIFICATION CHAMBER AND (B)(4) TEMPERATURE/FLOW PROBE. FISHER & PAYKEL HEALTHCARE IMMEDIATELY RAISED AN INQUIRY TO OBTAIN PERTINENT DETAILS IN RESPECT OF THE CIRCUMSTANCES SURROUNDING THE INCIDENT AND TO SEEK CONFIRMATION OF THE PATIENT CONSEQUENCE. THIS PROCESS IS CURRENTLY UNDERWAY.

    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 FISHER & PAYKEL HEALTHCARE'S MR850 RESPIRATORY| 900MR860 TEMPERATURE/FLOW PROBE| MR290 HUMIDIFICATION CHAMBER| HUMIDIFIER