BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 696221 · Received April 5, 2006

    Report

    Report Number
    2936999-2006-00137
    Event Type
    Death
    Date Received
    April 5, 2006
    Date of Event
    February 23, 2006
    Report Date
    March 22, 2006
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DEVELOPED A CUFF LEAK WHILE IN USE ON A PATIENT. WHEN THE LEAK OCCURRED THE PATIENT COULD NOT BE VENTILATED. THE PATIENT WAS DESIGNATED TO BE A DNR AND INI (DO NOT RESUSCITATED AND DO NOT VENTILATE) PATIENT. THE CALLER REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ENDOTRACHEAL TUBE CBH JUAREZ HENEQUEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death