BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON

    MDR report key: 17349714 · Received July 19, 2023

    Report

    Report Number
    17349714
    Event Type
    Death
    Date Received
    July 19, 2023
    Date of Event
    June 23, 2023
    Report Date
    June 29, 2023
    Manufacturer
    HAMILTON MEDICAL INC.
    Product Code
    QOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STAFF STATES THAT THE VENTILATOR SPONTANEOUSLY CHANGED FIO2 SETTINGS FROM 100% TO 30%. A NURSE ENTERED ROOM AND FOUND NO SPO2 REPORTING AND PATIENT HEART RATE OF 18. AFTER VERIFYING SETTING WITH RESPIRATORY, NURSE INCREASED TO 100%. DATA VALIDATION FROM THE VENT SHOWS FIO2 DECREASED TO 30% AT 19:23 AND WAS INCREASED TO 100% AT 19:32. HAMILTON MEDICAL REP NOTIFIED ON (B)(6), 2023. THE VENT WAS SEQUESTERED AND EVENT LOGS PULLED AND SENT TO MFR ON 06/26/2023. FINAL RESULTS HAVE NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36481 HAMILTON CONTINUOUS VENTILATOR QOS HAMILTON MEDICAL INC. C6

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death