BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2221534 · Received August 17, 2011

    Report

    Report Number
    2031702-2011-00174
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    August 16, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD NO FLOW WITH AN AUDIBLE ALARM WHILE CONNECTED TO THE PT. THE PT'S O2 SATURATIONS WERE FALLING. THE RESPIRATORY THERAPIST BEGAN TO MANUALLY VENTILATE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention