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	03/18/2026
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 device log files for analysis.Review of the logs showed that the ventilator generated technical event (b)(6) (blower speed low), as well as technical fault 446029 (ambient failure detected) and technical fault 431001 (blower fault).During troubleshooting, it was identified that the required preventive maintenance had not been performed on the device on their side, as this service had been contracted with a third-party company.The provided images show that the fan is visibly dirty.The ventilator experienced a documented blower failure with associated ambient-state transition.The blower assembly was subsequently replaced.Following replacement, the technical faults were no longer observed.A complete service and software check was performed, with all tests passing successfully.The device was returned to use.This case is considered closed.
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that during ventilation, the device stopped suddenly.The device alarmed with te231009.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: 24738769
• Report Number: 3001421318-2026-00173
• Device Sequence Number: 10421948
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)230203(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/31/2026

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2023
• 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