MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: during startup, a hamilton-c3 ventilator displayed multiple technical events related to the qvent flow sensor, and the self-test failed.The qvent sensor is responsible for measuring internal gas flow and is directly connected to the mainboard.After replacing the mainboard, the ventilator started up correctly, with no patient involved.
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (summary of the reporter): the complaint was received with the description: self-test failed with tf 431008 (q ventflow sensor error technical fault), (technical event - (te) 231012 (q ventflow sensor defect technical event).No patient was involved and no harm was reported.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.
Additional Manufacturer Narrative
Hamilton medical ag has not received the device or the mainboard for investigation.No further information has been received.However, the on-site technician confirmed that the mainboard was replaced, and the device functioned as intended thereafter.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: it was reported that a hamilton-c3 ventilator showed technical event (te) and technical fault (tf) alarms during startup.These alarms were linked to the qvent flow sensor, and the device did not pass its self test.The log files confirmed these alarms.The qvent flow sensor measures the airflow inside the device and is connected directly to the mainboard.The field service team found that the mainboard was the cause of the issue, since it communicates with the flow sensor.After replacing the mainboard, the ventilator started normally and worked without any further errors.Based on the information available, no patient was involved.The case is considered closed.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 22892689
• Report Number: 3001421318-2025-00771
• Device Sequence Number: 17638903
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)200910(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,Followup
• Report Date (Section B): 01/26/2026

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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/02/2025; Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/06/2025; 01/26/2026
• Date Device Manufactured: 09/10/2020
• 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