BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2504893 · Received March 23, 2012

    Report

    Report Number
    2031702-2012-00080
    Event Type
    Injury
    Date Received
    March 23, 2012
    Report Date
    March 23, 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
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS MAKING A HIGH PITCHED WHINING NOISE, WAS AUTOCYCLING, AND WAS ALSO VERY HOT TO THE TOUCH. THE PT WAS TURNING BLUE DURING THE AUTOCYCLING ISSUES AND WAS SENT TO THE EMERGENCY ROOM.

    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 NI Hospitalization| L