BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2431207 · Received January 18, 2012

    Report

    Report Number
    2031702-2012-00023
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    November 9, 2011
    Report Date
    January 18, 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
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR RESET MULTIPLE TIMES WITH AN AUDIBLE ALARM WHILE CONNECTED TO A PT. IT WAS ALSO REPORTED THAT THE VENTILATOR WAS NOT DELIVERING BREATHES. THE PT WAS MANUALLY VENTILATED WITHOUT COMPLICATIONS. THE PT WAS PLACED ON ANOTHER VENTILATOR.

    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 NI Required Intervention