BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 8105520 · Received November 27, 2018

    Report

    Report Number
    8105520
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    October 27, 2018
    Report Date
    November 13, 2018
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PATIENT CONNECTED TO VENTILATOR, THE MINUTE VENTILATION WAS READING VERY HIGH (GREATER THAN 33 LITERS). HOWEVER, THE PATIENT WAS BREATHING SIXTEEN BREATHS PER MINUTE. MESSAGE: CHECK EXPIRATORY FILTER. RESPIRATORY THERAPIST CHANGED OUT FLOW SENSOR AND EXPIRATORY FILTER. AFTER THAT IT WOULD NOT PASS CALIBRATION. THIS PARTICULAR VENTILATOR HAS HAD TWO SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947010 EVITA INFINITY VENTILATOR CBK DRAGER, INC. V500

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA