BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2327299 · Received November 7, 2011

    Report

    Report Number
    9611451-2011-00687
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    September 21, 2011
    Report Date
    October 13, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    REFER TO 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 COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE OF THE BREATHING CIRCUIT 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 TYPE FOR LOT 110901. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE FAILURE. 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS AN OPEN CIRCUIT ON THE INSPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT.THIS WAS FOUND PRIOR TO PATIENT USE.

    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 110901

    Patients

    Seq Age Sex Outcome Treatment
    1