BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 1873666 · Received October 13, 2010

    Report

    Report Number
    2031702-2010-00201
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS FOUND DISCONNECTED FROM VENT FOR AT LEAST 15 MINS. IT WAS UNK IF THE VENTILATOR ALARMED WHEN THE REPORTED PROBLEM OCCURRED. THE NURSE PERFORMED CPR AND THE PT WAS TAKEN TO HOSPITAL. THE PT IS BACK HOME. THE NURSE WAS ARRESTED. THERE ARE NO ALLEGATIONS THAT VENTILATOR MALFUNCTION CAUSED PT HARM.

    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 3 YR Hospitalization| L| R