MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
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.Logfiles analysis confirmed that on the reported event date, the device generated the respective technical faults and events.106|2026-06-10 05:10:51|!!! |technical event:231009.104|2026-06-10 05:26:25|!! |technical event:244018.95|2026-06-10 05:26:31|tf |446029.96|2026-06-10 05:26:31|tf |1746004.97|2026-06-10 05:26:31|tf |431001.98|2026-06-10 05:26:31|tf |1446029.99|2026-06-10 05:26:31|tf |1485001.Tf446029 - ambient failure detected.Te 231009 - blower controlled speed low.Tf431001 - blower fault.Tf446029, tf1446029, tf1485001 - ambientfailuredetected.Tf1746004 - panelerrorfailuredetected.Te 244018 - 24 v secondary voltage out of tolerance.To address the issue, the blower module was replaced.Following installation, the replacement blower module generated technical fault (tf) 232006, indicating a defective blower temperature sensor.Subsequent troubleshooting confirmed that the issue originated from the newly installed blower module.As a result, the blower module was replaced and the issue was resolved.The device passed the service software checks and returned to use.Hamilton medical ag considers this case closed.
Event or Problem Description
Hamilton medical ag received the following description: during the ventilation of a patient, the device was alarmed with the following technical faults and event: te 231009 ; tf1485001; tf1446029; tf431001 ; tf1746004 ; tf446029.The device was replaced with another one.No harm to the patient was reported.

• 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: 25649561
• Report Number: 3001421318-2026-00388
• Device Sequence Number: 15912349
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)211001(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/29/2026

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: 06/15/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• 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