BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE EVITA 2

    MDR report key: 9763901 · Received February 26, 2020

    Report

    Report Number
    MW5093337
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 24, 2020
    Manufacturer
    GE MEDICAL SYSTEMS INFO TECHNOLOGY
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    PT VENT ALARM WAS GOING OFF. FOUND THAT VENT NOT CYCLING AND O2 LEVEL WAS LOW. VENT CIRCUITS WAS CHECKED FOR LEAKAGE AND NONE WAS FOUND. PT CHECKED AND ETT TUBE CUFF PRESSURE WAS CHECKED. NO INDICATION OF LEAKAGE NOTED. FLOW SENSOR AND O2 WAS CALIBRATED. ALL CONNECTIONS ARE CHECKED AND SECURED. VENT MONITOR WAS STILL NOT SHOWING ANY CYCLE. PT WAS REMOVED FROM THE VENT AND STARED AMBU BAGGING WITH 100% FIO2 AND PEEP 10 DUE TO PT O2 SATURATION DROPPED TO 60%. PT O2 SATURATION SLOWLY INCREASED ALL THE WAY TO 100%. VENT WAS CHANGED WITH NEW VENTILATOR DRAGER XL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222787 GE HEALTHCARE EVITA 2 VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS INFO TECHNOLOGY 403249907 E 7

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention