MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "hospital staff says that while ventilating the patient, the device switched to standby mode without interaction from staff.Please see complaint form." no health consequences or impact.Patient removed from device and placed on another.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
Hamilton medical ag ref.Nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: it was reported per the provided complaint form; while ventilating a patient, the device switched to standby mode without staff interaction, triggering patient monitor alarms (oximetry/hr).The respiratory therapist responded, found the vent in sb with the patient connected, attended to the patient, then reviewed the events screen, which showed "missing times/data".The patient was removed from the device and switched to a different one; however, there was no harm to patient, user or third party, nor a treatment in delay.The device was reset and restarted, then removed from service and sent to customer's biomed for review.Review of device logs indicate the device switching from volume targeted (s)cmv+ mode to standby on december 7 with alarms: inspiratory volume limitation, disconnection on patient side, inspiratory volume limitation, vt low, and maximum leak compensation; and switching from (s)cmv+ to pcv+ was noticed on december 8 with alarms: 'external flow sensor failed', 'check flow sensor tubing', and 'sensor failure mode'.The device switching to pcv+ (pressure controlled) is expected if the device detects issues in the flow sensor measurement.It was advised for the customer to complete full service software to reveal any potential issues with the device.Service software tests were performed and the customer was unable to duplicate the issue.The partner was instructed to advice the customer to check for moisture, obstruction, or other issues to allow the flow sensor to detect flow and thus prevent the device switching modes from volume targeted to pressure controlled.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: 24000941
• Report Number: 3001421318-2026-00007
• Device Sequence Number: 13389188
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)181031(240)161001
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2018
• 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