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

Model Number	161006
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc lndustrial vial 10; domat/ems 7013 ; SZ 7013
• MDR Report Key: 24619841
• Report Number: 3016723884-2026-00002
• Device Sequence Number: 10224404
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: 07630002801850
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2026
• Report Date (Section F): 03/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: 161006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/17/2026