MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Hamilton medical ag ref.Conclusion: the hamilton-t1 ventilator triggered repeated ¿exhalation obstructed¿ alarms at the start of ventilation.No harm occurred, but the device had to be removed from service and replaced.The customer reported the event date as (b)(6) 2026.Log file analysis showed that the device was not in clinical use on that date.The alarms occurred on (b)(6) 2026 as well as earlier identical alarms dating back to (b)(6) 2026.No harm to patient, user or third party was reported.However, there was a need for medical intervention as the ventilator had to be replaced.The root cause of the reported issue was established as a defective expiratory valve assembly.The problem was resolved by replacing the expiratory valve assembly.No further information was received.Case is considered closed.
Event or Problem Description
Hamilton medical ag received the following event description (summary): it was reported that the hamiltion-t1 ventilator alarming "exhalation obstruction" at start of ventilation.No health consequences or impact occurred, was reported.The unit had to be removed from service.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24543044
• Report Number: 3001421318-2026-00114
• Device Sequence Number: 5661983
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)251022(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown