BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4298759 · Received December 4, 2014

    Report

    Report Number
    9611451-2014-00904
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 14, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT266 INFANT CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY AND THE EXPIRATORY HEATER WIRES WAS TESTED USING A CALIBRATED MULTIMETER. CONTINUITY TESTING AND VISUAL INSPECTION WERE ALSO CONDUCTED TO CHECK THE ELECTRICAL CONNECTION BETWEEN THE HEATER WIRES AND THE HEATER WIRE PINS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. THE ELECTRICAL RESISTANCE TEST SHOWED THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT. CONTINUITY TEST AND VISUAL INSPECTION REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATER WIRE WAS LOCATED AT THE CONNECTION BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. THE ELECTRICAL RESISTANCE OF THE EXPIRATORY HEATER WIRE WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140304. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION OF THE HEATER WIRE PIN DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT266 INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. WE WERE INFORMED THAT THE BREATHING CIRCUIT MALFUNCTIONED AFTER A "FEW DAYS" OF USE AND HAD THUS BECOME OPEN CIRCUIT WHILE IN USE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT265 STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. 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 TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR850 HUMIDIFIER GAVE A HEATER WIRE DISCONNECT ALARM AFTER A FEW DAYS OF USE WITH AN RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785256 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 140304

    Patients

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