BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA 2 DURA

    MDR report key: 274718 · Received April 20, 2000

    Report

    Report Number
    2517967-2000-00022
    Event Type
    Injury
    Date Received
    April 20, 2000
    Date of Event
    March 18, 2000
    Report Date
    April 20, 2000
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE BEING USED ON THE PT, THE VENTILATOR WAS DELIVERING 4-6 BEATS PER MINUTE WHEN THE VENTILATOR WAS SET TO 14 BEATS PER MINUTE. VENTILATOR ALARMS SOUNDED. THE PT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. IT WAS REPORTED THAT THE PT EXPERIENCED ADVERSE REACTIONS OF ARRHYTHMIA AND OXYGEN DESATURATION. PT'S CONDITION IMPROVED WHEN PLACED ON THE OTHER VENTILATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention