BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 404765 · Received July 12, 2002

    Report

    Report Number
    2517967-2002-00054
    Event Type
    Death
    Date Received
    July 12, 2002
    Date of Event
    June 12, 2002
    Report Date
    July 12, 2002
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THIS WAS A VERY SICK PT, CHRONIC ALCOHOLIC, LIVER DISEASE, CARDIAC COMPLICATIONS, WHO WAS NOT EXPECTED TO LIVE. THE PT WAS ADMITTED TO THE HOSP FOR CHOLECYSTITIS. THE PT WAS PLACED ON THE VENTILATOR BECAUSE OF RESPIRATORY ARREST. THERE REPORTEDLY WAS A CONFLICT BETWEEN THE RESPIRATORY THERAPIST AND THE PT'S FAMILY REGARDING THE CARE BEING PROVIDED. THE THERAPIST GAVE THE FAMILY THE IMPRESSION THAT THERE WAS SOMETHING WRONG WITH THE VENTILATOR. THE PT WAS MOVED TO ICU, HAD A SECOND RESPIRATORY ARREST, AND DIED SEVERAL DAYS LATER. RISK MANAGEMENT REPORTED TO DRAEGER MEDICAL, INC. THAT A REVIEW OF THE PULSE OXIMETER AND EKG READING INDICATED THAT THERE WAS NO VENTILATOR MALFUNCTION CAUSING OR CONTRIBUTING TO THE PT'S DEATH. IT WAS ALSO REPORTED THAT THE FAMILY OF THE PT HAS RETAINED AN ATTORNEY AND THE THERAPIST HAS BEEN FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR BSZ DRAEGER MEDICAL, INC. 4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death