MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: upon starting operation of the hamilton-c6, the device fails to reach the programmed tidal volume.The pre-use check procedure was optimized, and the unit was restarted with new consumables, but the issue persisted.Active humidification settings were also adjusted¿considering that excessive condensation might be interfering with measurements¿but this did not resolve the problem either.Despite optimizing the setup of consumables, the pre-use check, and humidification settings, the issue remained unresolved.The replacement and verification of the complete patient circuit were reported as the medical intervention performed.No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4) investigation ongoing.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 50881637
• Report Number: 3001421318-2026-00596
• Device Sequence Number: 18807544
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)190405(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 160021
• Device Catalogue Number: 160021
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/05/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown