BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2421036 · Received January 11, 2012

    Report

    Report Number
    2031702-2012-00013
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    November 17, 2011
    Report Date
    January 11, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DELIVERED NO FLOW TO THE PATIENT. THERE WAS AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. THE PATIENT WAS MANUALLY VENTILATED UNTIL HE WAS PLACED ON ANOTHER VENTILATOR. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention