BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON

    MDR report key: 17287963 · Received July 10, 2023

    Report

    Report Number
    0002937708-2023-00011
    Event Type
    Death
    Date Received
    July 10, 2023
    Date of Event
    December 1, 2020
    Report Date
    July 10, 2023
    Manufacturer
    HAMILTON MEDCIAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER: HAMILTON MEDICAL INC COULD NOT FIND DOCUMENTATION IF THIS CASE WAS PREVIOUSLY REPORTED. THIS REPORT CREATED AND SUBMITTED ON 10JULY2023.

    Description of Event or Problem · 0

    THE USER REPORTS THAT THE VENTILATOR WAS ALARMING O2 SUPPLY FAILED. USER STATED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655022 HAMILTON HAMILTON-G5 CBK HAMILTON MEDCIAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death