BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCH IV HUMIDIFIER

    MDR report key: 1591064 · Received January 25, 2010

    Report

    Report Number
    3003898360-2010-00034
    Event Type
    Death
    Date Received
    January 25, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 11, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WILL BE NO SAMPLE RETURNED. A FOLLOW-UP INVESTIGATION WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A PT EXPIRED WHILE USING THE CONCHA IV HUMIDIFIER. COMPLAINT ALSO STATES THAT IT WAS NOT INDICATED FROM THE FACILITY THAT THE TELEFLEX CONCH IV HUMIDIFIER CONTRIBUTED TO THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCH IV HUMIDIFIER HUMIDIFIER BTT TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death