BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2834191 · Received November 15, 2012

    Report

    Report Number
    9611451-2012-00826
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT380 ADULT DUAL-HEATED 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 K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A MULTIMETER. RESULTS: THE VISUAL INSPECTION REVEALED NO VISIBLE DAMAGE TO THE COMPLAINT BREATHING CIRCUIT. THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT. A WIRE BREAK WAS LOCATED IN THE OVERMOULDED PLUG A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT CAUSED AN ALARM DURING SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 120628

    Patients

    Seq Age Sex Outcome Treatment
    1