BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONETIC

    MDR report key: 1696535 · Received May 19, 2010

    Report

    Report Number
    2031702-2010-00097
    Event Type
    Injury
    Date Received
    May 19, 2010
    Report Date
    May 19, 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
    WV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS SET WITH A PRESSURE SUPPORT SETTING OF 25 CMH2O AND THE DELIVERED PRESSURE WAS APPROXIMATELY 5 CMH2O. THE VENTILATOR HAD AUDIBLY ALARMED FOR LOW PRESSURE AND THE LOW PRESSURE ALARM AND PRESSURE SUPPORT LIGHT FLASHED CONTINUOUSLY. AFTER THE PATIENT WAS PLACED ON THE BACK-UP VENTILATOR, THE PATIENT'S BREATH RATE, HEART RATE, AND O2 LEVELS RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention