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

Model Number	1610060
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During patient care hamilton ventilator began to alarm "low oxygen".O2 source was checked and confirmed on portable o2 tank.Ventilator was then placed on the onboard aircraft oxygen system, low o2 alarms continued.Additional portable tank attempted and low o2 alarms persisted.During flight "failed o2 source" alarm.Patient began to desaturate during flight - this was after 10 mins of continuous alarms and troubleshooting.Patient was removed from vent and bagged with bvm on 15lpm.Vent was checked - all connections, hoses, o2 sources verified - oxygen tank full.Onboard oxygen was running- unable to resolve the issue.Additional info provided: 1.Aircraft o2 interface/regulator model: essex medical systems plus 2.Hose type, and information on whether a quick-connect was used: high pressure o2 line (medical oxygen respironics reorder # (b)(4)) and there was no quick-connect system used.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; parc industrial vial 12; domat/ems 7013 ; SZ 7013
• MDR Report Key: 25362209
• Report Number: 3016723884-2026-00005
• Device Sequence Number: 9984735
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2026
• Report Date (Section F): 06/02/2026

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: 1610060
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/16/2026
• Event Location: Other
• Date Report to Manufacturer: 06/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/02/2026