BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2071311 · Received April 28, 2011

    Report

    Report Number
    9611451-2011-00258
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K034026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THIS INFORMATION AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION RECEIVED FROM THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. IT SHOULD BE NOTED THAT THE COMPLAINT WAS REPORTED TO FISHER & PAYKEL HEALTHCARE TWO MONTHS AFTER THE INCIDENT OCCURRED. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE VISITED THE HOSPITAL UPON RECEIPT OF THE COMPLAINT AND CHECKED ALL SERVICE RECORDS OF THE FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIERS. THE HUMIDIFIER INVOLVED IN THIS SET UP HAS CONFIRMED TO BE IN USE SINCE THIS EVENT WITHOUT INCIDENT. THE MR850 RESPIRATORY HUMIDIFIER HAS SEVERAL SAFETY FEATURES, INCLUDING AN AUDIBLE AND VISUAL ALARM, WHICH ALERTS THE USER IF THE TEMPERATURE EXCEEDS 41 DEGREES CELSIUS AND DISABLES THE HEATER. THE HUMIDIFIER ALSO HAS A THERMAL CUTOUT ON THE HEATER PLATE WHICH LIMITS THE MAXIMUM TEMPERATURE OF THE GAS ENTERING THE SYSTEM. WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED "BURN" TRAUMA. BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, THE HOSPITAL HAS REPORTED THAT THEY DO NOT BELIEVE THERE IS ANY DEFECT WITH THE COMPLAINT BREATHING CIRCUIT. NO FURTHER INFORMATION HAS BEEN PROVIDED WITH REGARD TO THE ALLEGED "BURN" TRAUMA, HOWEVER THE HOSPITAL HAS REPORTED THAT THE PATIENT IS IN SATISFACTORY CONDITION. THE RT225 USER INSTRUCTIONS ADVISE THE USER TO: - "AVOID PROLONGED CONTACT WITH THE PATIENT'S SKIN"

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT ALLEGEDLY SUSTAINED A "BURN TRAUMA" WHILE BEING VENTILATED WITH AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT. CURRENT STATUS OF THE PATIENT HAS BEEN REPORTED TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT ALLEGEDLY SUSTAINED A "BURN TRAUMA" WHILE BEING VENTILATED WITH AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT. CURRENT STATUS OF THE PATIENT HAS BEEN REPORTED TO BE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention EVITA 4 VENTILATOR| FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER| FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER| EVITA 4 VENTILATOR