BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 4132984 · Received September 29, 2014

    Report

    Report Number
    3003898360-2014-00757
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 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

    PRODUCT USAGE WHEN ALLEGED DEFECT WAS ENCOUNTERED IS UNK. THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. PER DHR (DEVICE HISTORY RECORD), THE PRODUCT CONCHA NEPTUNE, SERIAL (B)(4) WAS MANUFACTURED ON (B)(4) 2010. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE UNIT DOES NOT HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606479 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1