BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3533322 · Received December 23, 2013

    Report

    Report Number
    9611451-2013-01075
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    November 25, 2013
    Report Date
    November 26, 2013
    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 LOCATED NEAR THE HEATER WIRE RETAINER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130814. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE OBSERVED DAMAGE ON THE INSPIRATORY HEATER WIRE. 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 20 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(6) 2013.

    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
    673229 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130814

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH MR850 RESPIRATORY HUMIDIFIER