BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONETIC

    MDR report key: 1613258 · Received February 17, 2010

    Report

    Report Number
    2031702-2010-00026
    Event Type
    Injury
    Date Received
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING TRANSITIONED OFF THE HOSP VENTILATOR AND ONTO A LTV VENTILATOR. IT WAS REPORTED THAT THE LTV VENTILATOR WAS AUTO CYCLING WHILE CONNECTED TO THE PT. THE PT WAS REMOVED FROM THE LTV VENTILATOR AND PLACED BACK ON THE HOSP VENTILATOR. AFTER A WHILE, THE PT WAS PLACED BACK ON THE LTV VENTILATOR. THE HOSP STAFF WENT TO CHECK ON THE PT AND FOUND THE PT WAS "GRAY" AND THE EXHALATION PRESSURE LINE WAS DISCONNECTED FROM THE VENTILATOR WITH NO AUDIBLE ALARM. THE PT WAS PLACED ON ANOTHER VENTILATOR. SINCE THE REPORTED PROBLEM, THE PT PASSED AWAY DUE TO A NON-VENTILATOR RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC LTV 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention