BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY 6XLT CD

    MDR report key: 9732671 · Received February 19, 2020

    Report

    Report Number
    MW5093098
    Event Type
    Death
    Date Received
    February 19, 2020
    Date of Event
    July 8, 2019
    Report Date
    February 17, 2020
    Manufacturer
    MEDTRONIC / COVIDIEN, LLC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TRACHEAL TUBE REPLACEMENT WAS PERFORMED BY (B)(6) (SKILLED NURSING FACILITY IN (B)(6)) ON (B)(6) 2019 AROUND 1700 HOURS FOR A (B)(6) Y/O PT. THE TYPE OF TRACHEAL TUBE WAS CHANGED FROM A SHILEY 6 DCFS CUFFLESS TO A LONGER TRACHEAL TUBE (SHILEY 6 XLT CD) DUE TO THE INCREASE IN THICK BLOODY MUCOUS SECRETIONS AND PT'S TROUBLE BREATHING ON FULL AC VENT SETTINGS. IMMEDIATELY AFTER THE PROCEDURE WAS PERFORMED, THE PT COMPLAINED OF SHORTNESS OF BREATH AND WENT INTO FULL CODE. THE UNRESPONSIVE PT WAS TRANSPORTED VIA AMBULANCE TO (B)(6) MED CTR AND RESUSCITATED. PT WAS PRONOUNCED ON (B)(6) 2019 AT 0154 HOURS BY THE EMERGENCY ROOM PHYSICIAN WHO STATED THAT THE DEATH WAS DUE TO AN IMPROPERLY PLACED TRACHEAL TUBE. THE (B)(6) SHERIFF'S DEPT CORONER'S OFFICE PERFORMED AN AUTOPSY AND INVESTIGATION AND RULED OUT THE DEATH DUE TO SUBCUTANEOUS EMPHYSEMA AND PNEUMOTHORAX STATUS POST REPLACEMENT OF TRACHEAL TUBE. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 04/13/2020 FOR REPORT MW5093098. REPORTER WANTED TO ADD MFR REPORT NUMBER 8020889-2020-00017 AND TO UPDATE THE LAST SENTENCE TO "THE (B)(6) SHERIFF'S DEPT CORONER'S OFFICE PERFORMED AN AUTOPSY AND INVESTIGATION AND RULED THE DEATH DUE TO SUBCUTANEOUS EMPHYSEMA AND PNEUMOTHORAX STATUS POST REPLACEMENT OF TRACHEAL TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188585 SHILEY 6XLT CD TUBE TRACHEOSTOMY AND TUBE CUFF JOH MEDTRONIC / COVIDIEN, LLC 60XLTCD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death