BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 4180364 · Received October 15, 2014

    Report

    Report Number
    3003898360-2014-00820
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECS. THE SAMPLE WAS NOT RETURNED FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE UNIT DOES NOT REACH ITS TEMPERATURE SET POINT. NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655740 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1