MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following description: following a successful completion of the preoperative checks, the ventilator was connected to a patient.Shortly thereafter, the device failed to deliver volume to the patient and generated a patient side disconnection alarm.The patient was transferred to another ventilator.No patient harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains also the investigation outcome, hamilton medical ag received the logfiles of the device for analysis.Review of the log files showed that the device repeatedly alarmed with "check flow sensor tubing," followed by "sensor failure mode was initiated," which subsequently led to a "patient-side disconnection" alarm.No technical events (tes), technical failures (tfs), or ambient mode activations were recorded.Subsequent inspection revealed that the ventilator failed both the preoperative tightness test and the flow sensor test.Further troubleshooting identified an audible leak originating from the inspiratory pathway during the tightness test.An ambient valve test was then performed and failed.To address the issue, the ambient valve was replaced, the device passed the service software checks and was returned to use.Hamilton medical ag considers this case closed.

• 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: 25467098
• Report Number: 3001421318-2026-00374
• Device Sequence Number: 16068733
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)240202(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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