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

Model Number	1610060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/17/2026
Type of Reportable Event	Death
Event or Problem Description
Oxygen quick connect on portable tank failed.Hose from ventilator appeared to be attached but apparently slipped from the connector causing patient to desaturate.Upon evaluation of the connector after the call, it was discovered that the quick connect was not properly latching.Have a video showing it malfunctioning but was unable to load due to size.

• Brand Name: HAMILTON-T1 CONFIGURED
• Common Device Name: HAMILTON T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc industrial vial 10; domat /ems 7013 ; SZ 7013
• MDR Report Key: 24338999
• Report Number: 3016723884-2026-00001
• Device Sequence Number: 4770661
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: 07630002813532
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/03/2026
• Report Date (Section F): 02/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1610060
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• 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 Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/13/2026