BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2990387 · Received March 5, 2013

    Report

    Report Number
    9611451-2013-00157
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 7, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE TUBES WERE VISUALLY INSPECTED AND ELECTRICAL RESISTANCE TESTED USING A MULTIMETER. RESULTS: THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS OUTSIDE THE SPECIFICATION. NO FAULT WAS FOUND WITH THE HEATER WIRE IN THE EXPIRATORY TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120903. CONCLUSION: THE FAULT OBSERVED 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. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE WAS DAMAGED 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT HAD AN OPEN CIRCUIT HEATER WIRE. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94133 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120903

    Patients

    Seq Age Sex Outcome Treatment
    1