BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2800063 · Received October 17, 2012

    Report

    Report Number
    2936999-2012-00533
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 18, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER IS A RESPIRATORY THERAPIST THAT IS CALLING FOR A PT THAT STATES THE PT IS COMPLAINING ABOUT THE TRACH FITTING DIFFERENTLY AND CAUSING SOME DISCOMFORT. CALLER STATES THAT THE TRACH HAS NOT BEEN REMOVED DUE TO THE DISCOMFORT BUT THAT THE PT CONTINUES TO STATE THE NEWER TRACHS FIT DIFFERENTLY. ON (B)(6) 2012, THE CALLER REPORTED THAT PT IS GOING TO HAVE THE TRACH CHANGED IN A COUPLE WEEKS AND THEY WILL TRY TO SAVE IT FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1