BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCHATHERM NEPTUNE HEATED HUMIDIFICATION SYSTEM

    MDR report key: 1635198 · Received March 16, 2010

    Report

    Report Number
    MW5015177
    Event Type
    Other
    Date Received
    March 16, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 12, 2010, THE MANAGER OF RESPIRATORY THERAPY REC'D A RECALL NOTICED FOR THE CONCHATHERM NEPTUNE HEATED HUMIDIFICATION SYS. THE RECALL WAS IN RELATION TO THE AMPS GOING THROUGH THE HEATING WIRES IN THE VENTILATOR TUBING. THE COMPANY CAME TO THE HOSPITAL IN THE LAST WEEK OF FEB AND DOWNLOADED SOFTWARE IN AN EFFORT TO FIX THE PROBLEM RELATED TO THE RECALL. ON (B) (6) 2010, THE RESPIRATORY THERAPIST ENTERED THIS PT'S ROOM TO ATTEND TO AN AUDIBLE VENTILATOR HEATER ALARM. ALL WIRES AND THE TEMP PROBE WERE CHECKED. THE HEATER WAS THEN TURNED OFF AND ON. THE CARDIAC MONITOR THEN ALARMED ASYSTOLE. THE NURSE ENTERED THE ROOM TO ATTEND TO THE ALARM AND ASSESS THE PT. THE HEATER WAS TURNED OFF AND THE CARDIAC MONITOR THEN READ NSR. THIS INTERFERENCE WITH CARDIAC MONITOR WAS NOTED ON 2 OTHER PTS OVER THE NEXT WEEK. THE COMPANY WAS NOTIFIED. ALL 25 HEATER HAVE BEEN REPLACED WITH A OLDER MODEL, THE CONTOUR HEATED HUMIDIFICATION SYS UNTIL THE ISSUE IS RESOLVED. THERE HAVE BEEN NO FURTHER ISSUES WITH INTERFERENCE WITH THE CARDIAC MONITORS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other