BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRAL MONITORING SYSTEM

    MDR report key: 10242 · Received October 8, 1993

    Report

    Report Number
    1317346-1993-00002
    Event Type
    Death
    Date Received
    October 8, 1993
    Date of Event
    August 10, 1993
    Report Date
    September 14, 1993
    Manufacturer
    CANADIAN MONAGHAN LIMITED
    Product Code
    CAP
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PULLED OUT HER SHILEY TRACH WHILE CONNECTED TO A LIFE CARE LP-6 CENTRAL MONITORING SYSTEM. RESIDENT'S NURSE WALKED IN AND FOUND PATIENT TURNING BLUE. STAFF INABLE TO VENTILATE PATIENT AS WHOLE TRACH SYSTEM WAS PULLED OUT, LEAVING NOTHING TO CONNECT AMBUBAG TO. NURSE STATES ALARM WAS NOT SOUNDING ON AIRWAY PRESSURE MONITOR OR VENTLIATOR. PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL MONITORING SYSTEM AIRWAY PRESSURE MONITORING SYSTEM CAP CANADIAN MONAGHAN LIMITED CM5000SC P344N

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death LIFECARE LP-6 SHILEY TRACH