BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER

    MDR report key: 2121720 · Received May 19, 2011

    Report

    Report Number
    3003898360-2011-00254
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 2, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 THE DURING MECHANICAL VENTILATION; A BURNED HOLE WAS FOUND IN THE (B)(4) HEATED WIRE CIRCUIT. COMPLAINT INDICATES THAT THE RESPIRATORY THERAPIST FORGOT TO TURN OFF THE HEATER AFTER TURNING OFF THE VENTILATOR. THE ALLEGED BURN HOLE WAS FOUND IN THE PROXIMAL PART OF THE CIRCUIT. THERE WERE NO PT INJURIES AS THE PT WAS OFF THE VENTILATOR.

    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 HUDSON WIRE CIRCUIT (NIV) NON INVASIVE| VENTILATION: (B)(4)