BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO 300A

    MDR report key: 1041339 · Received April 24, 2008

    Report

    Report Number
    1041339
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STRONG BURNING SMELL WAS COMING FROM THE VENTILATOR. ONE REPORT OF SMOKE BEING EMITTED BUT THAT COULD NOT BE CONCLUSIVELY VERIFIED. THE PATIENT WAS JUST TRANSFERRING INTO THE ROOM AND THE VENTILATOR WAS BEING USED ON THIS PATIENT FOR THE FIRST TIME. IT WAS REMOVED FROM SERVICE AND SENT TO BIOMED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO 300A VENTILATOR CBK MAQUET, INC. 300A *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR