BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2992902 · Received February 28, 2013

    Report

    Report Number
    2936999-2013-00126
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THAT THE INNER CANNULA IS NOT STAYING LOCKED IN PLACE BUT DOES NOT KNOW HOW LONG THIS TRACH HAD BEEN IN PLACE BEFORE THIS HAPPENED. THE CALLER DID NOT SUGGEST THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. CALLER INDICATED NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87319 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1