BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE HEATED HUMID. KIT

    MDR report key: 3123700 · Received May 14, 2013

    Report

    Report Number
    3004365956-2013-00133
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE REPORTED LOT NUMBER THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. PRODUCT IFU DOCUMENT REVIEWED. THE PRODUCT IFU STATES SEVERAL WARNINGS IN ORDER TO AVOID OVERHEATING THE CIRCUIT AND INSTRUCTIONS FOR USE OF THE PRODUCT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF THE SAMPLE AT THE TIME OF THIS REPORT. HOWEVER, BASED ON THE CUSTOMER COMPLAINT DESCRIPTION THE PRODUCT WAS USED AGAINST IFU WARNINGS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE FLOW ON THE TOP KINKED. "WHEN THE RT CHANGED THE WATER BOTTLE, SHE MAY HAVE CLAMPED THE TUBE IN THE SAME POSITION AS THE KINK, THEN UN-CLAMPED THE TUBE. THE FLOW TUBE REMAINED KINKED NOT ALLOWING WATER TO FILL THE COLUMN. THE PATIENT PLUGGED OFF THE TRACHEOSTOMY REQUIRED A BRONCHOSCOPY AND THE NEPTUNE HEATER WAS REPLACED WITH A F&P UNIT." INTERVENTION- BRONCHOSCOPY. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212767 HUDSON CONCHATHERM NEPTUNE HEATED HUMID. KIT HEATED HUMIDIFIER & CIRCUIT KIT BTT TELEFLEX MEDICAL 02A1301159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention