BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300A

    MDR report key: 1000171 · Received January 23, 2008

    Report

    Report Number
    1225700-2008-00008
    Event Type
    Malfunction
    Date Received
    January 23, 2008
    Date of Event
    October 16, 2007
    Report Date
    January 11, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMOKE SMELL CAME FROM THE VENTILATOR, WHILE IT WAS CONNECTED TO A PT.

    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 *