BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24543826 · Received March 9, 2026

    Report

    Report Number
    3001421318-2026-00115
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 9, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    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); HAMILTON MEDICAL AG CONCLUSION: INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED A REPORT STATING THAT A PATIENT¿S OXYGEN LEVELS BECAME VERY LOW BEFORE HOSPITAL STAFF NOTICED IT. IT IS NOT KNOWN WHETHER THE VENTILATOR ALARMS WERE ACTIVATED OR WHETHER THE HOSPITAL MONITORING SYSTEM HAD AN ISSUE. THE INFORMATION WAS PROVIDED DURING A PHONE CALL WITH THE BIOMEDICAL DEPARTMENT. THE DEVICE HAS NOT YET BEEN EVALUATED AND WILL BE SENT TO TECHNICAL SUPPORT. THE BIOMEDICAL DEPARTMENT COULD NOT PROVIDE ADDITIONAL DETAILS ABOUT THE EVENT OR WHAT ACTIONS WERE TAKEN. ADDITIONAL DEVICE WAS REQUIRED AND HARM WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607992 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown