MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1; HAMILTON T1

Model Number	161006
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2026
Type of Reportable Event	Death
Event or Problem Description
Unknown date of death.Customer states ventilator was involved in a sentinel event.T.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc lndustrial vial 10; domat / ems, graubunden 7013 ; SZ 7013
• MDR Report Key: 25616120
• Report Number: 3016723884-2026-00009
• Device Sequence Number: 10195081
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: 07630002813532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2026
• Report Date (Section F): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 161006
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/24/2026