BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2669619 · Received July 25, 2012

    Report

    Report Number
    9611451-2012-00500
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 26, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY AND EXPIRATORY LIMBS OF THE COMPLAINT RT240 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR FURTHER EVALUATION. THE HEATER WIRES OF BOTH LIMBS WERE RESISTANCE TESTED USING A MULTIMETER. RESULTS: THE RESISTANCE TEST REVEALED THAT THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS HIGHER THAN NORMAL AND WAS OUT OF SPECIFICATION. THE EXPIRATORY HEATER WIRE WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120419. CONCLUSION: RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE HEATER WIRE WENT OUT OF SPECIFICATION DURING USE, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT240 BREATHING CIRCUIT CAUSED AN MR850 HUMIDIFIER TO DISPLAY A LOW TEMPERATURE ALARM AND THAT WHEN THE CIRCUIT WAS SWITCHED OUT THE HUMIDIFIER NO LONGER ALARMED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT240 BREATHING CIRCUIT CAUSED AN MR850 HUMIDIFIER TO DISPLAY A LOW TEMPERATURE ALARM AND THAT WHEN THE CIRCUIT WAS SWITCHED OUT THE HUMIDIFIER NO LONGER ALARMED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT240 120419

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO I VENTILATOR| FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER| SERVO I VENTILATOR| FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER