BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2213641 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00493
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSPIRATORY LIMB OF THE COMPLAINT RT235 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. A BENT PIN TEST WAS PERFORMED TO SEE IF THE CIRCUIT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. A HEATER WIRE ADAPTOR COULD NOT BE FULLY CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. ONE OF THE INSPIRATORY HEATER WIRE PINS WAS FOUND TO BE 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. ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. 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 TRANSPORT OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HUMIDIFIER CABLE COULD NOT CONNECT TO THE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT AS ONE OF THE HEATER WIRE PINS WAS SLIGHTLY BENT. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1