BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER

    MDR report key: 2121721 · Received May 19, 2011

    Report

    Report Number
    3003898360-2011-00253
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE HEATER DID NOT ALARM WHEN THE TEMP PROBE CAME OUT OF THE CIRCUIT. THE NEONATOLOGIST STATED THAT THE HEATER GOT REALLY HOT AND THE ODOR OF BURNING PLASTIC COULD BE SMELLED. THE HEATER WAS BEING USED WITH A (B)(4) COMFORT FLO HUMIDIFICATION SYSTEM AND WAS ENCLOSED IN AN ISOLETTE. THE TEMP PROBE WAS POSITIONED AT THE PT END. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER HEATED HUMIDIFIER BTT TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COMFORT FLO HUMIDIFICATION SYSTEM, (B)(4)