BEUDAMED
    FDA Adverse Event Death Summary report: N

    E100I

    MDR report key: 254916 · Received December 15, 1999

    Report

    Report Number
    2023050-1999-00010
    Event Type
    Death
    Date Received
    December 15, 1999
    Date of Event
    October 11, 1999
    Report Date
    December 9, 1999
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "A PT EXPIRED AFTER BECOMING DISCONNECTED FROM THE VENTILATOR. WHEN FOUND IT WAS ALSO NOTED THAT THE VENTILATOR WAS OFF AND NOT ALARMING. THE ISSUE WAS REPORTED SEVERAL WEEKS AFTER THE EVENT AND TWO VENTILATORS SEQUESTERED. DUE TO THE DELAY IN REPORTING, THERE WAS NO WAY TO RULE OUT WHICH OF THE TWO VENTILATORS WAS INVOLVED. BOTH WERE TESTED AND FOUND TO BE IN WORKING ORDER. CO IS REPORTING THIS AS A CASE OF USER ERROR." THIS IS DESCRIPTION OF INCIDENT AS REPORTED BY NMI'S CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E100I VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E100I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death