BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4513964 · Received February 12, 2015

    Report

    Report Number
    9611451-2015-00068
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 15, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT380 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION AND WAS VISUALLY INSPECTED. A HEATER WIRE RESISTANCE TEST OF THE INSPIRATORY AND EXPIRATORY HEATER WIRE WERE CARRIED OUT USING A CALIBRATED MULTIMETER. RESULTS: THERE WAS NO VISIBLE DAMAGE TO THE COMPLAINT DEVICE. THE RESISTANCE TEST REVEALED THAT THE EXPIRATORY HEATER WIRE WAS WITHIN SPECIFICATION AND THE INSPIRATORY HEATER WIRE WAS OUT OF SPECIFICATION. CONTINUITY TESTING AND VISUAL INSPECTION REVEALED THAT THE HIGH RESISTANCE IN THE INSPIRATORY LIMB HEATER WIRE WAS DUE TO A POOR CONNECTION BETWEEN THE HEATER WIRE AND THE CONNECTOR PINS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT DATE 140804. CONCLUSION: HIGH ELECTRICAL RESISTANCE IN HEATER WIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION OF THE HEATERWIRE AND THE HEATERWIRE PINS DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY DURING THE PERIOD OF USE. ALL RT380 ADULT BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT INSPIRATORY HEATERWIRE MALFUNCTIONED AFTER RELEASE FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 ADULT 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". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR850 HUMIDIFIER SOUNDED A HEATER WIRE DISCONNECT ALARM AFTER ONE DAY OF USE WITH AN RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106173 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 1408040301

    Patients

    Seq Age Sex Outcome Treatment
    1