MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (summary of the reporter): on (b)(6) 2025 at 15:57:14, the device triggered a technical event (te) 231032 alarm during active ventilation and switched to ambient mode.Prior to this, a high minute volume alarm had been observed.The issue was reproducible (means was re-constructible) : pressing the start ventilation button consistently led to the same te alarm and ambient mode activation.The event occurred two days after a blower module replacement.During inspection, expiratory valve calibration was performed via service software (adj/calib and pneumatic 1), and both tests passed successfully.The patient was transferred to another ventilator.No harm was reported.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: it was reported that a hamilton-c3 ventilator, during ventilation, displayed high minute volume alarms, then technical event te231032 (expiration valve disconnection), and entered ambient mode, stopping ventilation.The patient was connected, was transferred to another ventilator, and no clinical signs, symptoms, or conditions were reported.Log files showed the sequence and recurring voltage related technical fault tf444004 (voltage out of tolerance).Expiratory valve calibrations were performed and passed without deviations.The returned mainboard showed no visible damage, passed manufacturer testing, and the fault was not reproducible (re-constructable).The device was restored in the field by replacing the mainboard; based on the available information, no patient harm occurred and the case is considered closed.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 22936502
• Report Number: 3001421318-2025-00759
• Device Sequence Number: 9893134
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)201014(240)160005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 160005
• Device Catalogue Number: 160005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown