BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2264866 · Received September 26, 2011

    Report

    Report Number
    9611451-2011-00603
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 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 K983112. METHOD: THE INSPIRATORY LIMB OF THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES OF THE RETURNED BREATHING CIRCUIT LIMB WAS TESTED USING A MULTIMETER. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE RESISTANCE WAS TOO HIGH AND WAS THEREFORE OUTSIDE OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100517. CONCLUSION: RESISTANCE TESTS AND VISUAL INSPECTION ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE RESISTANCE BECAME HIGH POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT WAS FOUND TO BE OPEN CIRCUIT BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 110727

    Patients

    Seq Age Sex Outcome Treatment
    1