BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2183465 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00457
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 15, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE INSPIRATORY HEATER WIRE OF THE RETURNED RT380 BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGED PINS AND TESTED TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT BE FULLY CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. A VISUAL INSPECTION REVEALED THAT ONE OF THE INSPIRATORY HEATER WIRE PINS WAS BENT. THIS PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET. A LOT CHECK WAS NOT PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CONCLUSION: IT IS POSSIBLE FOR THE USER TO DAMAGE THE HEATER WIRE PINS DURING USE, FOR EXAMPLE, IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT PINS REPORTED TO US BY HEALTH CARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE PINS ON THE INSPIRATORY LIMB OF A RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WERE BENT. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT380

    Patients

    Seq Age Sex Outcome Treatment
    1