MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference:(b)(4); hamilton medical ags conclusion: investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description (summary): it was reported that the device unexpectedly shut down and triggered tf444001 (batteries total discharge / battery totally discharged), after which it switched into ambient mode condition.The patient was disconnected from the hamilton-c3, and the user provided manual ventilation.The device was then restarted successfully and powered on normally, allowing ventilation to be resumed.The device was later inspected and found to be operating normally.The investigation to verify the allegation is still in progress.

• 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: 24765557
• Report Number: 3001421318-2026-00188
• Device Sequence Number: 21148956
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)190701(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): 05/29/2026

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
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2019
• 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