BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCALAID PROFILE TRACHEOSTOMY TUBE

    MDR report key: 1113563 · Received June 6, 2008

    Report

    Report Number
    1217052-2008-00081
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 9, 2008
    Manufacturer
    MANUFACTURED FOR SMITHS MEDICAL BY: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTL LTD, HAS BEEN NOTIFIED OF AN EVENT THAT AIR LEAKAGE THROUGH THE CUFF WAS FOUND AFTER TUBE WAS IN USE FOR ONE DAY. UNIT WAS PRETESTED PER INSTRUCTIONS FOR USE. NO ADVERSE OUT COME. EVENT OCCURRED IN A FOREIGN COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCALAID PROFILE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH MANUFACTURED FOR SMITHS MEDICAL BY: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * 801917

    Patients

    Seq Age Sex Outcome Treatment
    1 * VENTILATOR