BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 2241467 · Received August 17, 2011

    Report

    Report Number
    3003898360-2011-00359
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE UNIT HAS NO AUDIO. THE REPORTED DEFECT WAS NOTICED DURING TREATMENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION DEVICE BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1