MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Event or Problem Description
Hamilton medical ag received the following event description: "while using this c1 on a patient, an alarm suddenly sounded and ¿safety ventilation¿ was displayed, so the hospital staff replaced the ventilator." there were no health consequences or impact.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Investigation outcome: the log file analysis shows the device operated normally and had been continuously in use since (b)(6) 2025.During the event on 29 december 2025 in asv mode, multiple technical failure alarms occurred within a short time, causing the device to correctly enter safety mode.The edrshow file indicates a software behavior on outdated software as the most probable root cause; update to version 3.1.0 or higher was performed.Additionally, the esm was replaced at the customer¿s request, but the first newly unpacked esm board showed a ¿data partition defect¿ on startup and was replaced again before c1 was returned to the hospital.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
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24050693
• Report Number: 3001421318-2026-00018
• Device Sequence Number: 9883521
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)231030(240)1610010
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 1610010
• Device Catalogue Number: 1610010
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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