BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2514547 · Received March 28, 2012

    Report

    Report Number
    2031702-2012-00085
    Event Type
    Injury
    Date Received
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS GIVING INCONSISTENT BREATHS. IT IS UNK IF THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. THE PT TURNED BLUE AND WAS MANUALLY VENTILATED. NO PT HARM REPORTED. THE VENTILATOR WAS BENCH TESTED LATER BUT NO PROBLEMS WERE FOUND.

    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 NI Life Threatening| R