BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 1905816 · Received November 19, 2010

    Report

    Report Number
    2031702-2010-00228
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 18, 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 VENTILATOR SHUT OFF AND WOULD NOT TURN BACK ON WHILE CONNECTED TO THE PATIENT. IT IS UNKNOWN IF THE VENTILATOR ALARMED WHEN THE REPORTED PROBLEM OCCURRED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. AT THE TIME OF THE INCIDENT, THE VENTILATOR WAS CONNECTED TO AN ELECTRICAL EXTENSION CORD FROM A NEIGHBORING HOUSE. THE DEALER REPORTED THAT THE VENTILATOR PASSED A FUNCTIONAL TEST.

    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 Hospitalization