BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1982990 · Received February 9, 2011

    Report

    Report Number
    9611451-2011-00066
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Report Date
    January 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT FROM THE CUSTOMER. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. WITHOUT A COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. NO LOT CHECK COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONDENSATION IN THE BREATHING CIRCUIT CAN BE CAUSED BY A NUMBER OF SETUP AND ENVIRONMENTAL FACTORS. COLD AIR SOURCES SUCH AS FANS, OPEN WINDOWS AND AIR CONDITIONING CAN CAUSE WARM HUMIDITY IN THE TUBE TO CONDENSE. THE HOSPITAL FURTHER REPORTED THAT THEY WERE OCCASIONALLY OPENING THE WINDOWS. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS SINCE VISITED THE HOSPITAL AND REPORTED THAT THEY ARE NOW USING RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WHICH ARE SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH AND NO FURTHER CONDENSATION ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT ON TWO DIFFERENT OCCASIONS CONDENSATION IN THE EXPIRATORY LIMB OF AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT CAUSED THE SERVO I VENTILATOR TO ALARM. AN FPH MR850 HUMIDIFIER WAS ALSO USED IN THE SETUP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT ON TWO DIFFERENT OCCASIONS, CONDENSATION IN THE EXPIRATORY LIMB OF AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT CAUSED THE SERVO I VENTILATOR TO ALARM. AN FPH MR850 HUMIDIFIER WAS ALSO USED IN THE SETUP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT200

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 HUMIDIFIER| SERVO I VENTILATOR| MR850 HUMIDIFIER| SERVO I VENTILATOR