BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-G5

    MDR report key: 8898343 · Received August 15, 2019

    Report

    Report Number
    2937708-2019-00010
    Event Type
    Death
    Date Received
    August 15, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 15, 2019
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED HAMILTON MEDICAL, INC. PERSONNEL FOR ASSISTANCE TO DOWNLOAD DEVICE EVENT LOGS. CUSTOMER STATED THAT A PATIENT HAD PASSED AWAY WHILE ON THE G5 AND "THE DAYSHIFT RT FOUND THAT THE LINES FOR THE FLOW SENSOR WERE REVERSED." ALTHOUGH VENTILATION CONTINUES, THE MONITORED DATA WOULD NOT BE A TRUE REPRESENTATION OF GAS FLOW IF THE PROXIMAL LINES WERE REVERSED. AS OF THE DAY OF THIS REPORT, NO DATA OR OBSERVATIONS INDICATE THE DEVICE DID NOT FUNCTION AS DESIGNED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692006 HAMILTON-G5 G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death