BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOVENT T

    MDR report key: 97526 · Received June 12, 1997

    Report

    Report Number
    1217052-1997-00026
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    May 12, 1997
    Report Date
    May 13, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CHILD ALLEGEDLY REMOVED THE THERMOVENT FROM HER TRACHEOSTOMY TUBE REPORTEDLY TO GET ATTENTION FROM HER CAREGIVER. THE CHILD HAS REMOVED THE FILTER MEDIA FROM THE FILTER HOUSING ON MORE THAN ONE OCCASION. ON 5/12/97, THE CHILD WAS FOUND CHOKING ON THE FILTER WHICH SHE HAD REMOVED. THE CAREGIVER REMOVED THE FILTER MEDIA AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOVENT T CONDENSER, HEAT AND MOISTURE BYD SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 611289

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO