BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-T1

    MDR report key: 24619841 · Received March 17, 2026

    Report

    Report Number
    3016723884-2026-00002
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 17, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENTS O2 LEVELS BECAME VERY LOW BEFORE IT WAS NOTICED BY HOSPITAL STAFF. NOT KNOWN IF THE DEVICE DID NOT ALARM OR IF HOSPITAL MONITORING SYSTEM HAD AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624892 HAMILTON-T1 HAMILTON T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R