BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2071793 · Received April 21, 2011

    Report

    Report Number
    2031702-2011-00086
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PT WAS TRAVELING IN THE CAR, THE VENTILATOR SHUT DOWN WITH AN AUDIBLE ALARM DUE TO A BATTERY EMPTY CONDITION. THEY THOUGHT THE VENTILATOR WAS RUNNING ON THE CIGARETTE LIGHTER PLUG WHEN IT REALLY WAS NOT. THE PT WAS AIR LIFTED TO THE HOSPITAL. NO PT HARM REPORTED. THE RESPIRATORY THERAPIST STATED THE DC ADAPTER AND VENTILATOR PASSED TESTING.

    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 6 YR Hospitalization| L