BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL VENTILATOR

    MDR report key: 6493071 · Received April 12, 2017

    Report

    Report Number
    MW5069090
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 27, 2017
    Manufacturer
    MAQUET MEDICAL SYSTEMS USA
    Product Code
    ONZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S VENT WAS ALARMING AND A UNUSUAL SMELL WAS COMING FROM THE VENT. VENT WAS RUNNING ON BACK UP BATTERY EVEN THOUGH IT WAS PLUGGED INTO THE ELECTRICAL OUTLET. VENT WAS IMMEDIATELY TAKEN OUT AND A NEW ONE WAS REPLACED. PATIENT WAS NOT HARMED AND IS SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269826 MECHANICAL VENTILATOR MECHANICAL VENTILATOR ONZ MAQUET MEDICAL SYSTEMS USA SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR