BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER BREATHING SYSTEM WITH CONTROLLER

    MDR report key: 610036 · Received June 3, 2005

    Report

    Report Number
    2014730-2005-00009
    Event Type
    Death
    Date Received
    June 3, 2005
    Date of Event
    May 5, 2005
    Report Date
    June 3, 2005
    Manufacturer
    TELEFLEX MEDICAL/ HUDSON RCI
    Product Code
    BZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON A VENTILLATOR. THE PATIENT'S AIRWAY WAS HUMIDIFIED WITH BREATHING CIRCUIT AND A CONCHATHERM IV HEATED HUMIDIFER. A HEALTH CARE PROFESSIONAL AT THE HOSPITAL DID NOT PUNCTURE THE WATER BOTTLE THAT DELIVERS WATER INTO THE HEATED HUMIDIFIER COLUMN. THE PATIENT DEVELOPED A MUCOUS PLUG AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATER BREATHING SYSTEM WITH CONTROLLER HEATED HUMIDIFIER BZE TELEFLEX MEDICAL/ HUDSON RCI NA B25313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death