BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 1246608 · Received November 21, 2008

    Report

    Report Number
    9611451-2008-00683
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 23, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL DEVICES AND ACCESSORIES ASSOCIATED WITH THIS INCIDENT HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. A THOROUGH INVESTIGATION IS CURRENTLY UNDERWAY. IN ORDER TO FURTHER ASSIST IN OUR ANALYSIS OF THE ROOT CAUSE OF THIS INCIDENT, FISHER & PAYKEL HEALTHCARE HAS MADE FURTHER INQUIRY IN RESPECT OF THE SURROUNDING THE EVENT, EQUIPMENT SET-UP AND USAGE. A TRANSLATION INTO THE ENGLISH LANGUAGE OF THE RESPONSES TO OUR QUESTIONS IS CURRENTLY BEING PREPARED AND THEREFORE, NOT YET AVAILABLE. WE WILL PROVIDE A FOLLOW-UP REPORT OUTLINING OUR ANALYSIS OF THE INCIDENT WHEN INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE AS FOLLOWS: A FIRE OCCURRED IN A SET-UP INVOLVING THE RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT ('THE BREATHING CIRCUIT') AND MR290 AUTOFEED HUMIDIFICATION CHAMBER ('THE MR290 CHAMBER'). THE FIRE OCCURRED IN THE VICINITY OF THE MR290 CHAMBER PORT AND BREATHING CIRCUIT CONNECTOR. OTHER COMPONENTS OF THE BREATHING CIRCUIT SET-UP INCLUDED THE MR700 RESPIRATORY HUMIDIFIER, 900MR900 HEATER WIRE ADAPTOR (LOT NUMBER 061019 AND 900MR569 TEMPERATURE PROBE (LOT NUMBER 060831) AND HUDSON NASAL CANULA (REF 41828). THE SET-UP HAD BEEN IN USE ON A PATIENT UNDERGOING LOW FLOW OXYGEN THERAPY AT A FLOW RATE OF 0.2 TO 0.3 L/MIN FOR A PERIOD OF 30-45 MINUTES. NEITHER THE PATIENT NOR MEMBERS OF THE MEDICAL TEAM SUSTAINED ANY INJURIES AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT329

    Patients

    Seq Age Sex Outcome Treatment
    1 AUTOFEED HUMIDIFICATION CHAMBER| FISHER & PAYKEL HEALTHCARE'S MR290| 900MR900 HEATER WIRE ADAPTOR| 900MR569 TEMPERATURE PROBE| MR700 RESPIRATORY HUMIDIFIER| HUDSON NASAL CANULA