MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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): "device went in ambient mode during ventilation.After completing my checks i found the plunger on the expiratory valve was sticking.".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: event date was corrected to 24.04.2025.Additional information: it was reported that a hamilton-c3 ventilator entered ambient mode during patient use on (b)(6) 2025.No medical intervention and no patient harm were reported.The log file shows that ambient mode occurred, as technical errors related to the ambient state condition were recorded in the logfiles shortly before ventilation stopped.According to the field technician, the event was associated with a sticking plunger inside the expiratory valve assembly.Based on the available information, the expiratory valve assembly (item number msp160240) was identified as the most probable cause of the malfunction.The assembly was replaced with a new original manufacturer part.All required functional and performance tests were completed in accordance with the service instructions.The device operated within specification and no further faults were observed.The ventilator returned to service and no additional information has been 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: 22606779
• Report Number: 3001421318-2025-00710
• Device Sequence Number: 9737437
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)210730(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): 02/18/2026

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: 06/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2021
• 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