MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation is still ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: low oxygen alarm appeared frequently on the hamilton-c3 device while used with 100% oxygen.The report stated that no health consequences occurred, and no clinical impact was observed.The patient was moved to another ventilator.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 frequent ¿low oxygen¿ alarms occurred during ventilation while the hamilton-c3 ventilator was operated with 100 percent oxygen, and an additional ventilator was required to continue patient ventilation.No patient harm was reported.The customer initially reported the event date as 21 oct 2025; subsequent clarification from the physician indicated the event occurred on 06 oct 2025.Log files from the time of the reported event were not available.Logfile review from (b)(6) 2026 did not identify any technical failures or ambient mode activation and showed operational alarms including ¿low oxygen.¿ as corrective action, the o2 sensor, the cable between the mainboard and o2 sensor, and the o2 inlet filter were replaced.Following replacement and observation, the ventilator passed service software checks and has been used without recurrence of the issue.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: 24625148
• Report Number: 3001421318-2026-00142
• Device Sequence Number: 9201334
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)250430(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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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