BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3982220 · Received August 5, 2014

    Report

    Report Number
    9611451-2014-00678
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT235 INFANT 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 AND EXPIRATORY HEATER WIRES WERE WITHIN SPECIFICATION. CONTINUITY TESTING REVEALED THERE WAS NO CONTINUITY BETWEEN THE RIGHT HEATER WIRE PIN AND THE HEATER WIRE IN THE INSPIRATORY LIMB. VISUAL INSPECTION IDENTIFIED THE OPEN CIRCUIT TO BE CAUSED BY A BREAK BETWEEN THE INSPIRATORY HEATER WIRE AND THE RIGHT HEATER WIRE PIN INSIDE THE OVER MOULDED PLUG. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE OBSERVED DAMAGE ON THE INSPIRATORY HEATER WIRE. 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 AND CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT235 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 THAT AN RT235 INFANT BREATHING CIRCUIT FAILED TO PROPERLY WARM "AIR FROM THE SYSTEM". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456400 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235

    Patients

    Seq Age Sex Outcome Treatment
    1