BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 1182573 · Received July 21, 2008

    Report

    Report Number
    1225700-2008-00113
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, THE RESPIRATORY THERAPIST SMELLED SMOKE, AND THE VENTILATOR WAS EXCHANGED. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *