BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON-C6

    MDR report key: 25146750 · Received May 12, 2026

    Report

    Report Number
    3001421318-2026-00295
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 12, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: A PATIENT PASSED AWAY WHILE ON VENTILATOR. NO ISSUES REPORTED WITH DEVICE. IT IS INDICATED THAT A MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, THE ACCOMPANYING COMMENT STATES: ¿PATIENT WAS REMOVED FROM DEVICE AS THE PATIENT HAD PASSED AWAY,¿ FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE REPORTED EVENT. THE CAUSALITY OF THE DEATH IN RELATION TO THE HAMILTON-G6 HAS NOT YET BEEN DETERMINED AND IS CURRENTLY UNDER INVESTIGATION. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41368 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death