BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3757765 · Received April 17, 2014

    Report

    Report Number
    9611451-2014-00354
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 19, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE INSPIRATORY AND EXPIRATORY HEATER WIRES WERE RESISTANCE TESTED USING A CALIBRATED MULTIMETER. RESULTS: THE RESISTANCE TEST REVEALED THAT THE INSPIRATORY HEATER WIRE WAS OUT OF SPECIFICATION. NO FAULT WAS FOUND WITH THE EXPIRATORY HEATER WIRE. CONTINUITY TESTING AND VISUAL INSPECTION REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATER WIRE WAS DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN INSIDE THE OVER-MOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 131113. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, RENDERING THE CIRCUIT UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION. ANY CIRCUIT THAT FAILS IS REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS". OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING ELECTRICAL OPEN CIRCUITS IN HEATER WIRES IN ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER (B)(4) SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF MARCH 2014.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS CAUSING THE MR850 TO ALARM WHEN THE HEATER WIRE ADAPTOR WAS CONNECTED. THIS WAS FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234866 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 131113

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH MR850 RESPIRATORY HUMIDIFIER