BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 7863728 · Received September 11, 2018

    Report

    Report Number
    7863728
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 30, 2018
    Manufacturer
    DRAEGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR STARTED MAKING LOUD VIBRATING SHAKING SOUNDS AND WAS RATTLING AT THE INSPIRATORY LIMB WHERE IT CONNECTS TO THE VALVE. THE DEVICE DID NOT DELIVER BREATHS APPROPRIATELY AND A JAGGED WAVE FORM WAS ON THE SCREEN. THE VENTILATOR WAS CHANGED. THIS WAS A POTENTIAL FOR HARM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704894 EVITA INFINITY VENTILATOR, CONTINUOUS, FACILITY CBK DRAEGER, INC. V500

    Patients

    Seq Age Sex Outcome Treatment
    1