BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 3181310 · Received June 7, 2013

    Report

    Report Number
    3003898360-2013-00225
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED SERIAL NUMBER (B)(4). THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. DOCUMENT ASSESSMENT FMEA (PRODUCT/PROCESS) WAS CONDUCTED AND NO CHANGES REQUIRED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253878 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX MEDICAL 425-00

    Patients

    Seq Age Sex Outcome Treatment
    1 PB 840 VENTILATOR| TELEFLEX HEATED WIRE CIRCUIT (CATALOG# 780-35)