BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 1890063 · Received October 28, 2010

    Report

    Report Number
    2031702-2010-00210
    Event Type
    Injury
    Date Received
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT DELIVER THE SET VOLUME WITHOUT AN AUDIBLE ALARM WHILE CONNECTED TO A PT. THE PT WAS MANUALLY VENTILATED AND PLACED ON ANOTHER VENTILATOR. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention