MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (summary of the reporter): during an emergency rescue, the hamilton-c2 ventilator failed and could not be used as intended.Medical staff immediately switched to a manual resuscitation bag to provide ventilation, which caused a brief delay in initiating respiratory support.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.
Additional Manufacturer Narrative
Hamilton medical reference: (b)(4).Hamilton medical ags conclusion: based on the evaluation of hamilton medical chinas report, it is confirmed that the hamilton-c2 failed during ventilation.An additional ventilator was required, as the patient had to be manually ventilated (bagged).The root cause of the failure could not be identified.The device was repaired by a third-party company; however, the replaced parts and the actual root cause remain unknown.As the device has reached the end of its life cycle, it was reported that it has been permanently removed from use.Based on the available information, hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 23741937
• Report Number: 3001421318-2025-00941
• Device Sequence Number: 8413643
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(11)150206(240)160002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121225
• 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): 12/08/2025

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: 160002
• Device Catalogue Number: 160002
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2015
• 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