BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2636694 · Received July 2, 2012

    Report

    Report Number
    9611451-2012-00428
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Report Date
    June 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY AND EXPIRATORY LIMBS OF THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES OF THE RETURNED BREATHING CIRCUIT LIMBS 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. THE EXPIRATORY LIMB HEATER WIRE WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 111020. CONCLUSION: RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE CUSTOMER HAD NOTED THAT THE CIRCUIT WAS OPERATING FOR 24 HOURS BEFORE IT FAILED, WHICH SUGGESTS THAT THE HEATER WIRE RESISTANCE BECAME HIGH DURING USE, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT340 ADULT BREATHING CIRCUIT WAS FOUND TO BE DEFECTIVE AFTER 24 HOURS OF 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 111020

    Patients

    Seq Age Sex Outcome Treatment
    1