BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300A

    MDR report key: 1111766 · Received June 4, 2008

    Report

    Report Number
    1225700-2008-00080
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 8, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR BEGAN TO SMOKE WHILE IN USE ON APT. THE PT WAS DISCONNECTED AND VENTILATED IN ACCORDANCE WITH THE FACILITY POLICY. THE PT WAS NOT HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 300A CBK CBK MAQUET CRITICAL CARE AB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *