BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2921891 · Received January 10, 2013

    Report

    Report Number
    2031702-2013-00002
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 2, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT CIRCUIT BECAME DISCONNECTED FROM THE PT WITHOUT AN ALARM FROM THE VENTILATOR. ACCORDING TO THE CAREGIVER, THE PT HAD TURNED "PURPLE" WHEN THE EVENT OCCURRED. THE PULSE OXIMETER ALARMED TO ALERT THE CAREGIVER. TESTING BY THE HOMECARE DEALER VERIFIED THAT THE VENTILATOR ALARMS PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15895 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R