BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E360 VENTILATOR

    MDR report key: 3935539 · Received June 23, 2014

    Report

    Report Number
    2023050-2014-00260
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    November 22, 2013
    Report Date
    June 3, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY BEING INVESTIGATED. AS ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN E360 VENTILATOR EXPERIENCED A "NO COMMUNICATION" ALARM, WHILE BEING USED ON A PATIENT. THE SCREEN WAS REPORTED TO BE BLANK AT THE TIME OF THE EVENT. A VUELINK CABLE WAS CONNECTED TO THE VENTILATOR TO CONTINUE COMMUNICATIONS AT THE TIME OF THE EVENT. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364629 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention