BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 2633098 · Received June 21, 2012

    Report

    Report Number
    2031702-2012-00160
    Event Type
    Death
    Date Received
    June 21, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 21, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THE PATIENT'S MOTHER CLAIMED THAT THE VENTILATOR WAS NOT WORKING PROPERLY BUT WAS UNABLE TO GIVE ANY FURTHER DETAILS. NINE-ONE-ONE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE HE PASSED AWAY. THE VENTILATOR DID NOT HAVE AN AUDIBLE ALARM WHEN THE REPORTED EVENT OCCURRED.

    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 Death