BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS

    MDR report key: 3517878 · Received December 12, 2013

    Report

    Report Number
    8030673-2013-00078
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZE
    PMA / PMN Number
    K915226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS IN THE PROCESS OF BEING SENT TO THE MANUFACTURING PLANT. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE EXPIRATORY LIMB OF CIRCUIT, RT4851-12, OVERHEATED AFTER 32ND DAY OF USE.  THE BURN FOLLOWED THE PATH OF THE HEATER WIRE. <BR /> SALES REP, (B)(6) HAS ONE SAMPLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013:ONE INCIDENT OF THE MELTED CIRCUIT, ON A F AND P HEATER MR850, THE MELTED CONDITION WAS NOTICED BY THE MOTHER AND ALERTED THE CLINICIANS. CIRCUIT WAS REPLACED, NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651611 CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION RT4851-12

    Patients

    Seq Age Sex Outcome Treatment
    1