BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 5957223 · Received September 16, 2016

    Report

    Report Number
    8020893-2016-02408
    Event Type
    Injury
    Date Received
    September 16, 2016
    Report Date
    August 18, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE INCLUDING THE DIAGNOSTIC LOG IN THE MEMORY LOG. SE COULD NOT DUPLICATE ANY MALFUNCTION. THE SE FOUND THE BREATH DELIVERY (BD) CABLE WAS NOT SECURE TO THE SIDE PANEL UNIT. THE BD TO GRAPHICAL USER INTERFACE ( GUI) CABLE WAS REPLACED. THE VENTILATOR PASSED ALL THE REQUIRED TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR DUE TO A MALFUNCTION. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608189 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention