BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE VERSAMED IVENT

    MDR report key: 9172258 · Received October 8, 2019

    Report

    Report Number
    MW5090282
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 2, 2019
    Manufacturer
    GE MEDICAL SYSTEMS INFOMATION TECHNOLOGIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    WHILE PT WAS HAVING MRI TESTING, VERSAMED IVENT ALARMED "LOW BATTERY" FOR APPROX 5 MINS DESPITE BEING PLUGGED INTO A RED EMERGENCY ELECTRICAL POWER OUTLET. ALARM THEN CHANGED TO "BATTERY DEPLETED", THE SCREEN CONTRAST TOGGLED BETWEEN BRIGHT AND DIM AND, UNIT CONTINUED TO VENTILATE PT FOR APPROX ANOTHER 5 MINS. THE VENTILATOR SCREEN ABRUPTLY WENT BLACK AND THE VENTILATOR SHUT DOWN DESPITE BEING PLUGGED INTO THE EMERGENCY WALL ELECTRICAL POWER SOCKET. PT WAS IMMEDIATELY REMOVED FROM VENTILATOR CIRCUIT AND MANUALLY VENTILATED WITH 100% O2. NO HARM CAME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959215 GE VERSAMED IVENT VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS INFOMATION TECHNOLOGIES, INC. 1.4.5.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R