BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3575352 · Received January 14, 2014

    Report

    Report Number
    9611451-2014-00033
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 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 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 ONE OTHER COMPLAINT 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".

    Description of Event or Problem · 1

    A HOSPITAL 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
    35961 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130814

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER