MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Codes	Failure of Device to Self-Test (2937); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: (1) detailed complaint and failure description: "self test failed." (2) no clinical signs, symptoms or conditions.No health consequences or impact.
Additional Manufacturer Narrative
The following was reported: "error occurred while checking before patient connection.Self-test failed.Technical event 231032.Checked and found problem in expiratory valve.Replaced the same.All tests and calibration passed in service software.Machine working fine." no patient involvement reported.Provided log files confirm the issue.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; CH 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 21089372
• Report Number: 3001421318-2025-00024
• Device Sequence Number: 8664763
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)171025(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 160001
• Device Catalogue Number: 160001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2017
• 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