BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 4132999 · Received September 29, 2014

    Report

    Report Number
    3003898360-2014-00773
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT CONCHA NEPTUNE, (B)(4) WAS MANUFACTURED ON (B)(4) 2009. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME, SINCE THE DEVICE IS NOT AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE ON/OFF SWITCH ON THE HEATER IS INTERMITTENTLY WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606481 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1