MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following complaint description (quotation of the customer/reporter): "while device was on standby we get audible/visible alarm and tf 485001, tf 446029, tf 446022, tf 446030 at random times.Startup procedure is ok and device passes service tests but while doing the tests i did get same tf codes once while doing o2 calibration and once when device was in service mode "main screen".Logs." health impact: no patient involvement.
Additional Manufacturer Narrative
Additional information: hamilton medical ag`s comes to the following conclusion: the log file analyses showed that the hamilton-c6 generated technical fault (tf) alarms with ambient state condition during service software in a non clinical service procedure despite passing startup and self-tests.The mainboard was identified as defective component and was replaced per service procedure.Post-replacement, the device passed all functional and safety tests.The hamilton-c6 is back in use.Corrected: section h6 imdrf codes were corrected/updated.
Additional Manufacturer Narrative
The correct affected device is hamilton-c2.Corrected conclusion with correct device: the log file analyses showed that the hamilton-c2 generated technical fault (tf) alarms with ambient state condition during service software in a non clinical service procedure despite passing startup and self-tests.The mainboard was identified as defective component and was replaced per service procedure.Post-replacement, the device passed all functional and safety tests.The hamilton-c2 is back in use.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 21642231
• Report Number: 3001421318-2025-00445
• Device Sequence Number: 18048464
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150625(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 160001
• Device Catalogue Number: 160001
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 09/11/2025; Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 09/11/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• 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