BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 3900216 · Received May 1, 2014

    Report

    Report Number
    3003898360-2014-00300
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RT DIRECTOR WAS CONCERNED THAT NO HEATER ALARM WENT OFF DURING THIS EVENT. THE ISSUE WAS DISCUSSED AND IT WAS CONCLUDED BY THE FACILITY AND SALES REPRESENTATIVE THAT BECAUSE THE MELTED PART WAS NOT LARGE; THERE WAS STILL FLOW THROUGH THE CIRCUIT. A VISUAL AND FUNCTIONAL 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, LOT #612060605 WAS MANUFACTURED ON 06/28/2012. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE 780-20 SINGLE LIMB BREATHING CIRCUIT WAS BEING USED, WITH THE CONCH NEPTUNE, ON A TRACH PATIENT IN A LONG TERM CARE FACILITY. THE BED RAIL WAS CLOSED ONTO THE CIRCUIT WHICH THEN CAUSED THE OUTER CASING TO MELT. THE COATING OVER THE WIRES IN THE CIRCUIT DID NOT MELT. NO PATIENT INJURY REPORTED. THE CONDITION OF THE PATIENT IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264154 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 HUDSON SINGLE LIMB BREATHING CIRCUIT (CAT#780-20)