BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G.E. VERSA MED TRANSPORT MRI COMPATIBLE VENTILATOR

    MDR report key: 4611845 · Received March 11, 2015

    Report

    Report Number
    MW5041484
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 22, 2015
    Manufacturer
    G.E.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VERSA MED SERIAL #(B)(4) WAS ALARMING. UPON ENTERING ROOM A STRONG SMOKE SMELL WAS OBSERVED. PT. WAS NOTICED NOT BEING VENTILATED WHILE ON VERSA MED. THE PT. WAS DISCONNECTED AND MANUALLY VENTILATED UNTIL ANOTHER VENTILATOR WAS BROUGHT IN. DIAGNOSIS OR REASON FOR USE: ACUTE/CHRONIC RESPIRATORY FAILURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166497 G.E. VERSA MED TRANSPORT MRI COMPATIBLE VENTILATOR VERSA MED (IVENT) CBK G.E.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R