BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2445276 · Received February 3, 2012

    Report

    Report Number
    2031702-2012-00044
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    December 23, 2011
    Report Date
    February 2, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITH NO AUDIBLE ALARM WHILE CONNECTED TO THE PT. THE PT WAS STRUGGLING TO BREATHE AND HAD TO BE MANUALLY VENTILATED UNTIL PLACED ON THE BACK-UP VENTILATOR. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 10950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Life Threatening| R