MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
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 ventilating a patient in spont mode, the device began triggering >100 breaths/min when apnea backup kicked in.Had to provide alternate means of ventilation, appears that flow trigger was attempted to increase to avoid it triggering." there was no report of harm to patient, user or third party, nor a treatment in delay.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: it was reported that while ventilating a patient in spont mode, the device began triggering >100 breaths/min (at 01:39:11, per questionnaire) when apnea backup kicked in.The rt attempted to mitigate potential auto-triggering by increasing the flow trigger from the default 5 to 8.The team provided alternate ventilation and the device was flagged for evaluation.However, there was no report of harm to patient, user or third party, nor a treatment in delay.A questionnaire was sent to the customer.Additional information was received from the provided questionnaire: "auto-triggering breaths, constant cycling-not triggered by patient.However, hamilton medical ag was informed that no more contact or follow up was expected from the customer.Therefore, the cause could not be established.This case is considered as closed.If further information is received that changes this assessment, a follow-up report will be submitted.

• 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: 23987449
• Report Number: 3001421318-2026-00005
• Device Sequence Number: 17284543
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)201019(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): 04/07/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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