BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2830995 · Received November 1, 2012

    Report

    Report Number
    2031702-2012-00281
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 19, 2012
    Report Date
    November 1, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S HUSBAND THAT THE PT DID NOT FEEL WELL ALL DAY. THE PT WOKE UP AROUND 9PM, SAT STRAIGHT UP IN BED, AND HER FACE WAS BLUE/PURPLE. THE VENTILATOR AND PULSE OXIMETER HAD AUDIBLE ALARMS. THE PT'S HUSBAND CALLED 911 AND THE PARAMEDIC INFORMED HIM TO KEEP HER ON THE VENTILATOR UNTIL THEY GOT THERE. THE EMS ARRIVED AND INITIATED CPR. THE PT WAS THEN TAKEN TO EMERGENCY ROOM AND ADMITTED TO THE ICU. THERE ARE NO ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTV VENTILATOR, CONTINOUS / CBK CBK CAREFUSION 203, INC. LTV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R