BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER

    MDR report key: 2182528 · Received July 8, 2011

    Report

    Report Number
    3003898360-2011-00302
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    June 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL PERTINENT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE HEATER OVERHEATED AND SUSTAINED BURNS ON THE EXPIRATORY SIDE OF THE HEATER. THE BURNS DETERIORATED THE HARNESS AND THE WIRES. THERE WAS A SMOKE-SMELL DETECTED DURING THE ALLEGED INCIDENT. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK