BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2268610 · Received September 28, 2011

    Report

    Report Number
    9611451-2011-00607
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Report Date
    August 30, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 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 K034026. LOT NUMBERS: 110414: X1, 110620: X1. DEVICE MANUFACTURING DATES: 04/14/2011, 06/20/2011. METHOD: TWO COMPLAINT DEVICES HAVE BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR VISUAL INSPECTION AND PERFORMANCE TEST. RESULT: THE VISUAL INSPECTION REVEALED NO DAMAGES FOUND ON BOTH COMPLAINT DEVICES. THE PERFORMANCE TEST REVEALED THAT THERE WAS CONDENSATION IN THE EVAQUA2 LIMBS WHEN THE HEATER WIRE WAS NOT CONNECTED, BUT NO CONDENSATION WAS OBSERVED WHEN THE HEATER WIRE WAS CONNECTED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBERS 110414 AND 110620. CONCLUSION: CONDENSATE IN THE HUMIDIFICATION SYSTEM, ALTHOUGH NOT PREFERRED, IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THE AMOUNT OF CONDENSATE IN THE VENTILATION SYSTEM IS INFLUENCED BY A NUMBER OF MULTIPLE SETUP AND ENVIRONMENTAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 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 K034026. ONE COMPLAINT DEVICE HAS RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND THE DEVICE EVALUATION IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT EXCESSIVE CONDENSATION WAS FOUND IN THE EXPIRATORY LIMB OF TWO RT265 INFANT BREATHING CIRCUIT KITS. AN INCREASE IN THE CO2 LEVELS OF THE PATIENTS WAS OBSERVED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT EXCESSIVE CONDENSATION WAS FOUND IN THE EXPIRATORY LIMB OF TWO RT265 INFANT BREATHING CIRCUIT KITS. AN INCREASE IN THE CO2 LEVELS OF THE PATIENTS WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1