MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).Replacement of driver board and control board resolved the issue.
Event or Problem Description
The following was reported to hamilton medical ag: "device came in with tes 231022 and 231036 and tfs 444004, 431002 & 285002.It was also failing the self test.The control board and driver board were replaced.All codes cleared and all tests passed.Device has gone back into service." no patient involvement.The case has not been reviewed yet by hamilton medical ag, therefore the failure description could not be confirmed yet.So far no relation to the device has been established.
Additional Manufacturer Narrative
Investigation outcome: the device alarmed for 'tf341009 pventpressuresensordefect' followed by various other technical events and failed the self test at start-up.The failure occurred multiple times on (b)(6) 2025.Later, in service software the device failed 'binary valve test' and 'autozero vent test'.It also alarmed for 'tf444004 voltage out of range' in service software multiple times.No patient involvement.The self-test functioned correctly, however, the test was not passed.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 an immediate or 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.Local service engineer identified driver board and control board as defective components.Replacement of these parts resolved the issue.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 Contact: christof mueller ; via crusch 8; bonaduz
• MDR Report Key: 22505439
• Report Number: 3001421318-2025-00694
• Device Sequence Number: 21182930
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)220118(240)161009
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 02/20/2026

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
• Device Model Number: 161009
• Device Catalogue Number: 161009
• Was Device Available for Evaluation?: No
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2022
• 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