BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4157771 · Received October 9, 2014

    Report

    Report Number
    9611451-2014-00808
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 16, 2014
    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

    METHOD: THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(6) FOR EVALUATION. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES OF THE INSPIRATORY AND EXPIRATORY LIMBS WAS TESTED USING A MULTIMETER. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE EXPIRATORY LIMB WAS WITHIN SPECIFICATION BUT THAT THE INSPIRATORY LIMB HEATER WIRE RESISTANCE 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 THAT NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR LOT DATE 140310. CONCLUSION: THE RESISTANCE OF THE INSPIRATORY LIMB HEATER WIRE WAS OUT OF SPECIFICATION. THIS WAS MOST LIKELY DUE TO A POOR CONNECTION BETWEEN THE HEATER WIRE AND THE CONNECTOR PINS THAT ONLY DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION. ALL RT340 BREATHING CIRCUITS ARE SUBJECTED TO A CONTINUITY TEST ON THE PRODUCTION LINE WHICH IS FOLLOWED BY A RESISTANCE TEST AND A VISUAL INSPECTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT BREATHING CIRCUIT WAS IN USE FOR FIVE DAYS BEFORE THE PROBLEM WAS OBSERVED, WHICH INDICATES THAT THE INSPIRATORY LIMB HEATER WIRE ONLY BECAME OUT OF SPECIFICATION AFTER IT WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TEMPERATURE OF AN RT340 ADULT BREATHING CIRCUIT DID NOT INCREASE WHEN CONNECTED TO AN MR850 HUMIDIFIER. THIS WAS OBSERVED AFTER FIVE DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635879 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 140310

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL MR850 HUMIDIFIER