MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Codes	Improper Flow or Infusion (2954); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: quotation from the reporter: "alarms with error code that patient is disconnected when all lines are secured to patient and ventilator.Issue occurred with several different crew shifts and while connected to an i-gel and ett.Other alarms present included low volume / hypoventilation with extremely low vte / mv values noted on screen." no harm to the patient was reported.
Additional Manufacturer Narrative
Investigation outcome: it was reported that device alarms for 'disconnection on patient side' sporadically.However, no disconnection can be evidenced, and all lines are secured to patient and ventilator.The issue occurred with several different crew shifts.On reviewing the device logs, it was noticed that this military t1 has been configured for 'manual oxygen limits activated' with oxygen (high) => 105 %, oxygen (low) => 95 % and oxygen => 100 % settings.Every time when the device is switched on or ventilation mode is changed the device defaults back to this setting.Consequently, the device frequently alarms for 'oxygen supply failed' when the device is not started with oxygen supply connected to the device.Also, on numerous occasions the fio2 setting was set outside dufault oxygen alarm limits, causing the device to alarm for 'low oxygen'.'disconnection on patient side alarm' along with other patient alarms occurred mostly together with 'oxygen supply failed' and 'low oxygen' alarms.The device has been following the same operating pattern as far back as the events log dates.It is clearly evidenced from device logs that this setting is not always being used as intended.If this is not the customers required device configuration, it should be considered deactivating the 'manual oxygen limit' option.No further information or feedback has been provided by the customer.However, the technician on site completed full service software and function checks with no issues.Device has been running on a test lung for approximately 18 hours with no issues.This case is considered as closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina valean ; via crusch 8; bonaduz
• MDR Report Key: 21570358
• Report Number: 3001421318-2025-00395
• Device Sequence Number: 8940310
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)220119(240)161009
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 161009
• Device Catalogue Number: 161009
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 01/19/2022
• 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