BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTIONAID PROFILE TRACHEOSTOMY TUBE

    MDR report key: 978464 · Received November 12, 2007

    Report

    Report Number
    1217052-2007-00151
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 2, 2007
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD., SMITHS MEDICAL
    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 INTERNATIONAL LTD., HAS BEEN NOTIFIED OF AN EVENT OF WHERE THE USER ALLEGES THEY HAD THE TUBE PLACED. ONE WEEK LATER, THE HOSP FOUND THE PILOT BALLOON DEFLATED WITH VENTILATOR ALARM. THE TUBE WAS REPLACED WITH ANTOHER ONE. 4.5 HOURS LATER VENTILATOR ALARM BEEPED AGAIN. THE PILOT BALLOON WAS FOUND TO BE DEFLATED. THE TUBE WAS AGAIN REPLACED. ONE HOUR LATER THE VENTILATOR ALARM BEEPED AGAIN. THE TUBE WAS REMOVED AND REPLACED WITH 100/517/075. NO LEAKAGE OCCURRED AFTER THAT TUBE REPLACEMENT. TUBES WERE PRETESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTIONAID PROFILE TRACHEOSTOMY TUBE 73 JOH - BREATHING TUBE JOH SMITHS MEDICAL INTERNATIONAL LTD., SMITHS MEDICAL * 122569

    Patients

    Seq Age Sex Outcome Treatment
    1 * VENTILATOR