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 description: upon starting operation of the hamilton-c6, the device fails to reach the programmed tidal volume.The pre-operational check was repeated, and new consumables were installed; however, the issue persisted.The active humidification system was also adjusted, as excessive condensation was suspected of affecting the measurements, but this did not resolve the issue.Despite optimizing the consumable setup, repeating the pre-operational check, and adjusting the humidification, the issue remains unresolved.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: via crusch 8; bonaduz 7402
• MDR Report Key: 50912498
• Report Number: 3001421318-2026-00606
• Device Sequence Number: 17475428
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)190408(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): 09/28/2026

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
• Operator of Device: Health Professional
• 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: 09/28/2026
• Date Device Manufactured: 04/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown