BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 2102895 · Received May 3, 2011

    Report

    Report Number
    2936999-2011-00307
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED, SHE THOUGHT THAT THE INNER CANNULA WAS BEING MADE THINNER AND THAT THEY ARE NOT BLOCKING THE AIR FROM THE VENTILATOR. SHE STATED THAT WHEN THE VENTILATOR GIVES A VOLUME, THE AIR BLOWS BETWEEN THE INNER AND OUTER CANNULA AND GOES THROUGH HER MOUTH. SHE STATED THAT SHE ONLY HAS THE SOLID INNER CANNULA TO USE WHEN SHE NEEDS NIGHTTIME VENTILATION. IN THE DAY TIME, SHE CAPS OFF THE TRACH. DURING THE CALL WITH THE COVIDIEN TECHNICAL SUPPORT SPECIALIST, THE CUSTOMER ALSO STATED, SHE CHANGES OUT THE TRACH EVERY 6 WEEKS. THE SPECIALIST REVIEWED THE DIRECTIONS FOR USE WITH THE CUSTOMER; THE TRACH NEEDS TO BE REPLACED EVERY 29 DAYS. THE CUSTOMER IS AWARE BUT STATED, HER DOCTOR SCHEDULES THE REPLACEMENT FOR EVERY 6 WEEKS. WHEN THE CUSTOMER HAS HER TRACH CHANGE AT THE HOSPITAL, THEY ONLY GIVE HER THE SOLID INNER CANNULA AND THE DCP. THE CUSTOMER STATED SHE HAD TWO OTHER TRACH CHANGES THAT WERE REPLACED ON SCHEDULE BUT WANTED TO REPORT THESE AS MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO 1006005388

    Patients

    Seq Age Sex Outcome Treatment
    1