MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (summary of the reporter): based on the information received from the complainant, the ventilator failed the self-test during startup and displayed multiple technical faults, including technical fault (tf) 431001 (blower fault).There was no patient involvement reported as the issue was at the start up.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: it was reported that a hamilton c3 ventilator entered ambient mode (ventilation stops) during patient ventilation.No medical intervention and no harm was reported.The log files analysis showed that ambient mode occurred.The field technician informed that a loose fdc (flexible display cable) to display cable was identified.Which is the most probable cause, leading to loss of communication and then to ambient mode.The cable was reconnected and all required checks and tests were completed.No parts were replaced.The device operated normally during testing.Device is back in use.No further information was received.The case is considered as closed.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 22607285
• Report Number: 3001421318-2025-00712
• Device Sequence Number: 9603664
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)190626(240)160005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 160005
• Device Catalogue Number: 160005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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