BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA

    MDR report key: 488600 · Received October 9, 2003

    Report

    Report Number
    2517967-2003-00132
    Event Type
    Injury
    Date Received
    October 9, 2003
    Date of Event
    September 30, 2003
    Report Date
    October 1, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT TRANSFERRED TO INTENSIVE CARE AND WAS CONNECTED TO THE VENTILATOR. THE PATIENT WAS NOTED TO BECOME BRADYCARDIC, WENT IN TO RESPIRATORY DISTRESS, AND THEN CARDIAC ARREST. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND STABILIZED. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL, INC. 2 DURA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention