BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLV-102

    MDR report key: 184330 · Received August 27, 1998

    Report

    Report Number
    MW1014478
    Event Type
    Death
    Date Received
    August 27, 1998
    Date of Event
    June 27, 1998
    Report Date
    August 18, 1998
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    06-26-98 2315. AWARE, ALERT AND ORIENTED, VENTILATOR SETTINGS CHECKED, ROUTINE CARE PROVIDED. CALL LIGHT WITHIN REACH 06-27-98 AT 0138. CHARGE NURSE SUMMONED TO ROOM. PT UNRESPONSIVE, TRACH DISLODGED. TRACH REINSERTED. AMBU BAGGED WITH 100% OXYGEN. NO RESPONSE. CARDIOPULMONARY RESUSCITATION INITIATED AND CODE BLUE ACTIVATED. EPINEPHRINE IN TRACH DUE TO NO INTRAVENOUS ACCESS. CODE BLUE CEASED AT 0200. PT PRONOUNCED. VENTILATOR SETTING: TIDAL VOL 850, HIGH PRESSURE 60, PEAK FLOW 50, LOW PRESSURE 10, RATE 11, PEAK PRESSURE 35 CM H2O, FIO2 40%, SIMV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLV-102 VENTILATOR CBK RESPIRONICS, INC. PLV-102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death GIBECK HME FILTER.