BEUDAMED
    FDA Adverse Event Death Summary report: N

    DALE TRACHEOSTOMY TUBE HOLDER

    MDR report key: 226075 · Received June 4, 1999

    Report

    Report Number
    1214422-1999-00001
    Event Type
    Death
    Date Received
    June 4, 1999
    Date of Event
    May 4, 1999
    Report Date
    June 3, 1999
    Manufacturer
    DALE MEDICAL PRODUCTS
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS FOUND WITH THE DALE TRACHEOSTOMY TUBE HOLDER DISENGAGED AND HIS OXYGEN MASK REMOVED. HE WAS CHECKED ON AT 3:30AM AND WAS VIEWED TO BE SLEEPING AND IN NO DISTRESS. HE WAS DISCOVERED AT 4:15AM WITH THE TRACHEOSTOMY TUBE HOLDER UNFASTENED. IT IS UNKNOWN HOW THE HOLDER BECAME UNFASTENED. THE HOSP IS CURRENTLY CONDUCTING AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE TRACHEOSTOMY TUBE HOLDER TRACHEOSTOMY TUBE HOLDER CBH DALE MEDICAL PRODUCTS 240 *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death