BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 3151346 · Received June 3, 2013

    Report

    Report Number
    3151346
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 20, 2013
    Report Date
    June 1, 2013
    Manufacturer
    DRAGER MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY TECH DISCONNECTED PATIENT FROM VENTILATOR (V500) TO SUCTION, AND WAS NOT ABLE TO RESTART THE VENTILATOR. WHEN BIOMED POWERED UP THE DEVICE IT GENERATED A DEVICE FAILURE 3 ALARM WHICH WAS NOT REPORTED BY THE RT AND THIS WAS NOT SEEN IN THE LOGS FOR THE RT INCIDENT EITHER. THE VENT LOST ITS USER CONFIGURATIONS, THERE WERE NO LOGS CAPTURED DURING THE TIME OF THE INCIDENT, AND THE STANDBY AND RUN TIME HOURS WERE RESET TO "0."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RESPIRATORY VENTILATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242391 EVITA INFINITY VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAGER MEDICAL, INC. EVITA INFINITY V500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR