BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2421018 · Received January 11, 2012

    Report

    Report Number
    2031702-2012-00010
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 11, 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
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR TURBINE WAS INTERMITTENTLY STOPPING AND STARTING WHILE CONNECTED TO A PATIENT. THE RN DID NOT REMEMBER ANY ALARM MESSAGES. THE PATIENT WAS BAGGED DURING THESE EVENTS AND THEN THE VENTILATOR WOULD START DELIVERING A BREATH AGAIN.

    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 51 YR Required Intervention