BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 1802485 · Received August 11, 2010

    Report

    Report Number
    8010042-2010-00164
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K970839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, A SMOKE ODOR WAS SMELLED AND THE VENTILATOR STOPPED SUDDENLY. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1