BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2974132 · Received February 13, 2013

    Report

    Report Number
    2031702-2013-00021
    Event Type
    Injury
    Date Received
    February 13, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS USING TOO MUCH OXYGEN WITH AN INTUBATED PATIENT USING ASSIST CONTROL. UNABLE TO GET THE VENTILATOR INTO A HI-PRESSURE O2 SETTING AND THE VENTILATOR STARTED AUTOCYCLING. THE TRANSPORT TEAM NEEDED TO MAKE AN UNSCHEDULED LANDING TO PICK UP MORE OXYGEN TO MAKE THE TRANSPORT. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64241 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention