BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2980050 · Received February 21, 2013

    Report

    Report Number
    2936999-2013-00116
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER INDICATED THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MANUFACTURING SITE FOR ANALYSIS, BUT HAS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE TUBE WAS IN THE PT AT HOME AND THE CARE PROVIDER SAID THAT THE CUFF WOULDN'T KEEP ITS PRESSURE. ABOUT A WEEK BEFORE IT WAS GOING TO BE REMOVED, SHE HAD TO INFLATE THE CUFF EVERYDAY BECAUSE IT KEPT GOING DOWN. ON THE DAY IT WAS BEING CHANGED SHE CHECKED THE CUFF PRESSURE IN THE MORNING AND IT HAD LOST ALL PRESSURE AND WAS COMPLETELY FLAT. THE CARE PROVIDER STATED THE PT WAS RECANNULATED ON THE DAY ROUTINE CHANGE WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75494 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1