MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference nr: (b)(4).Investigation outcome: based on the logfile analysis, the sequence of technical events and faults consistently indicates an unstable power supply during device start-up and operation.Multiple voltage-related faults, including voltage out of tolerance and ambient failure detections, occurred alongside sensor, alarm, and emergency-off related defects.The delayed registration of the 3v3, 5v, and 12v rails, together with the complete absence of the 3v3 backup voltage in the error log, further supports the presence of a fundamental power integrity issue.The observed fault pattern is therefore most likely associated with a defective control board.Replacing the control board is expected to restore correct voltage supply and resolve the reported failures.The technician on site was instructed to exchange the control board to solve the problem.However, no feedback has been received.This case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: "while using this t1, the messages ¿blower failure¿ and ¿ventilation interrupted¿ suddenly appeared, and the alarm continued to sound.Because the hospital staff immediately replaced the ventilator, the patient was not harmed.".

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24342439
• Report Number: 3001421318-2026-00069
• Device Sequence Number: 13220604
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)200626(240)161006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/16/2026

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: 161006
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2020
• 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