MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: when this c1 ventilator was being used on the patient in pcv+ mode, an alarm suddenly sounded, and the screen displayed te246015, 485001, 433001, and 446029, after which the ventilation operation stopped.Ventilator had to be replaced.However, there was no harm to the patient.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag reference nr: (b)(4).Investigation outcome: the device was operating normally for several months.All relevant checks before the event, including the leak test and flow sensor calibration on (b)(6) 2025, were successful and did not indicate any underlying problem.On (b)(6) 2026 at around 14:58, several technical faults occurred almost at the same time.Switch to ambient state, a timeout in the breath monitoring function, and a watchdog failure.Shortly after, the device reported battery communication errors.The system then experienced a fatal system crash and after restarted, returning to ventilation software at 15:05:43.The analysis the logfile shows multiple power supply values being reported as extremely low and physically impossible.This strongly indicates that the device was no longer receiving valid data, rather than experiencing a real power supply failure.The most likely root cause was identified as a communication problem between the esm and the control and/or driver board.This communication failure led to invalid measurements, missed timing signals, and watchdogs.To correct the issue and prevent recurrence, replacement of the control board or the esm is recommended.This case is considered as closed.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• 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: 24243707
• Report Number: 3001421318-2026-00046
• Device Sequence Number: 9618270
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)231123(240)1610010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 161001
• Device Catalogue Number: 161001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 11/23/2023
• 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