BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2213733 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00494
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. (B)(4). THE INSPIRATORY AND EXPIRATORY LIMBS OF THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH THE EXPIRATORY AND THE INSPIRATORY TUBES OF THE RETURNED BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE WAS OPEN CIRCUIT. A CONNECTION BREAK WAS FOUND BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN. THE ELECTRICAL RESISTANCE TEST SHOWED NO FAULT FOR THE EXPIRATORY LIMB HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100517. RESISTANCE TESTS AND VISUAL INSPECTION ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT WAS FOUND TO BE OPEN CIRCUIT BEFORE USE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 100517

    Patients

    Seq Age Sex Outcome Treatment
    1