MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610090
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "device visually alarming wth technical event 231008".No patient involved.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4) investigation ongoing.
Additional Manufacturer Narrative
Investigation outcome: the following was reported: "device visually alarming wth technical event 231008".No patient involvement.The reported technical event occurred during the self-test at startup and the te231008 is a predictable outcome of the test.The self-test is performed during the ventilator's startup process, prior to patient connection.This test ensures that the ventilator's components, including alarms, sensors, and circuits, are functioning correctly.It is a standard safety feature to ensure that the ventilator is functioning correctly before it's used on a patient.A failed self-test does not indicate a malfunction but rather was designed to prevent it.It serves as a security check to ensure all systems are functioning properly.If self-test is failed, it does not imply immediate danger, but rather alert an issue that needs to be addressed to prevent future problems.In conclusion, a failed self-test is not a critical failure, but part of the pre-emptive safety and maintenance measure.As soon as the underlying issue is addressed properly, the ventilator can be safely used on patients.The o2 mixer assembly was replaced and the device started up and worked as intended.This case is conisdered 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: 21558373
• Report Number: 3001421318-2025-00393
• Device Sequence Number: 11893875
• Product Code: CBK
• UDI-Device Identifier: 07630002813549
• UDI-Public: (01)07630002813549(11)210414(240)1610090
• 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): 01/26/2026

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: 1610090
• Device Catalogue Number: 1610090
• 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: 01/26/2026
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 01/26/2026
• Date Device Manufactured: 04/14/2021
• 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