BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE

    MDR report key: 2982668 · Received February 25, 2013

    Report

    Report Number
    3003898360-2013-00071
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 31, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED SERIAL NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. FMEA (PRODUCT/PROCESS) ASSESSMENT WAS CONDUCTED AND NO CHANGES ARE REQUIRED. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION AT THE TIME OF THIS REPORT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING THE VENTILATION, THE NEPTUNE STOPPED WORKING BY CREATING A MUCUS PLUG IN THE TRACHEAL TUBE. CONDITION OF PATIENT IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79523 HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER BZE TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1