BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 2910040 · Received December 6, 2012

    Report

    Report Number
    3003898360-2012-00559
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED SERIAL NUMBER. THE DHR DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE DEVICE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, AT THE TIME OF THIS REPORT. TELEFEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED VIA MEDWATCH. THE HEATED WIRES IN VENTILATOR CIRCUIT HEATED UP EXCESSIVELY RESULTING IN THE PLASTIC CIRCUIT MELTING. THE VENTILATOR ALARM SOUNDED WHICH ALERTED THE TECHNICIAN. UPON INSPECTION A HOLE WAS FOUND IN THE CIRCUIT AND A LEAK IN THE SYSTEM. THE PATIENT WAS BVM (BAG-VALVE-MASK) VENTILATED AND THE VENTILATOR WAS CHANGED OUT. THE HUDSON CONCHA NEPTUNE WAS THE HEATED HUMIDIFICATION SYSTEM USED IN THIS EVENT. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR HUDSON VENTILATOR CIRCUIT: CAT #780-32| MDR#3004365956-2012-00321