BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3074039 · Received April 24, 2013

    Report

    Report Number
    9611451-2013-00323
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) WHERE THE HEATER WIRES OF THE INSPIRATORY AND EXPIRATORY LIMBS WERE RESISTANCE TESTED. RESULTS: THE RESISTANCE TEST REVEALED THAT THE INSPIRATORY LIMB HEATER WIRE WAS OPEN CIRCUIT AND OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120620. 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. 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 BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE HEATER WIRE ADAPTOR WAS FAULTY ON AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. UPON RECEIVING THE DEVICE FOR INVESTIGATION IT WAS REVEALED THAT THE HEATER WIRE OF THE INSPIRATORY LIMB WAS OUT OF SPECIFICATION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176499 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120620

    Patients

    Seq Age Sex Outcome Treatment
    1