BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3756249 · Received April 17, 2014

    Report

    Report Number
    2031702-2014-00092
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S TRACH HAD COME OUT AND THE PULSE OXIMETER WAS ALARMING. IT WAS ALSO REPORTED THAT THE NURSE HAD APPARENTLY QUIETED THE PULSE OXIMETER ALARM. THE PATIENT HAD LOST ALL COLORING AND WAS IN DISTRESS. CPR WAS INITIATED, 911 WAS CALLED, AND THE PATIENT WAS TRANSFERRED TO THE PICU. THE PATIENT'S MOM REPORTED THAT SHE HEARD THE VENTILATOR'S AUDIBLE ALARM WHEN SHE WENT INTO THE PATIENT'S ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235114 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| L| R