BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 2574577 · Received May 9, 2012

    Report

    Report Number
    2031702-2012-00120
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    March 27, 2012
    Report Date
    May 9, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PT'S FAMILY STATED THAT THE VENTILATOR'S HIGH PRESSURE ALARM WENT OFF FOLLOWED BY THE LOW PRESSURE ALARM. THIS HAPPENED CONTINUOUSLY UNTIL THE PT WAS REMOVED AND MANUALLY VENTILATED. THE 911 WAS CALLED AND THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM. THE VENTILATOR WAS EXCHANGED THAT DAY. ON (B)(6) 2012, THE SAME ALARM SITUATION OCCURRED. THE PT WAS REMOVED AND MANUALLY VENTILATED. THE 911 WAS CALLED AND THE PT WAS TAKEN TO THE EMERGENCY ROOM WHERE HE LATER CODED AND PASSED AWAY.

    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 Death