BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 7977032 · Received October 18, 2018

    Report

    Report Number
    7977032
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    May 2, 2018
    Report Date
    October 11, 2018
    Manufacturer
    DRAEGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS INTUBATED UNDER GENERAL ANESTHESIA IN OR AND DRAEGER EVITA VENTILATOR WAS USED. THE VENTILATOR STOPPED BREATHING FOR PATIENT. THE DEVICE FAILURE CODE DISPLAYED WAS 13.03.001. THE VENTILATOR WAS REPLACED AND THE FAILED VENTILATOR WAS BROUGHT TO CLINICAL ENGINEERING FOR TROUBLESHOOTING. THE PATIENT SEEMED TO SUFFER NO ILL EFFECTS FROM THE VENTILATOR FAILURE.

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED UNDER GENERAL ANESTHESIA IN OR AND DRAEGER EVITA VENTILATOR WAS USED. THE VENTILATOR STOPPED BREATHING FOR PATIENT. THE DEVICE FAILURE CODE DISPLAYED WAS 13.03.001. THE VENTILATOR WAS REPLACED AND THE FAILED VENTILATOR WAS BROUGHT TO CLINICAL ENGINEERING FOR TROUBLESHOOTING. THE PATIENT SEEMED TO SUFFER NO ILL EFFECTS FROM THE VENTILATOR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818806 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER, INC. EVITA XL

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA