MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.(b)(4).Investigation is ongoing.
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): the ventilator reportedly shut off, displayed a blank screen, and could not be powered down until the batteries were removed.After rebooting, multiple technical error codes were displayed.A technician was scheduled to inspect the device onsite.The returned questionnaire indicated no patient involvement and no intervention necessary.The investigation to verify the allegation is still in progress.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 24320884
• Report Number: 3001421318-2026-00062
• Device Sequence Number: 21315001
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)250808(240)1610060
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 161006
• Device Catalogue Number: 1610060
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 08/08/2025
• 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