BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 2093298 · Received April 15, 2011

    Report

    Report Number
    3003898360-2011-00157
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. A FOLLOW-UP WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTED AS: COMPLAINT STATES THE CANNULA CAME OUT OF BABY'S NOSE AND THE BABY'S FACE ROLLED OVER ON IT. RAINOUT FROM THE CANNULA LEAKED OUT AND THE BABY RECEIVED BURNS ON IT'S FACE THAT REQUIRED TREATMENT. CANNULA WAS ATTACHED TO A CONCHA NEPTUNE HEATED HUMIDIFIER AND COMFORT FLOW KIT. ADDITIONAL INFORMATION REGARDING SEVERITY OF BURNS AND THE INCIDENT HAS BEEN REQUESTED FROM RISK MANAGEMENT BUT NOT RECEIVED IN TIME FOR THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other