MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that a hamilton-c1 (product no.161001, s/n: (b)(6), sw 3.0.3) experienced technical fault (tf) tf785003 (pm channel observation failed).Log review identified repeated occurrences of tf785003 together with tf444004 (voltage out of tolerance), tf446029 (ambient failure detected), and tf485001 (ambient failure detected).No patient involvement, harm, or medical intervention was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference: (b)(4); hamilton medical ags conclusion: it was reported that a hamilton-c1 (product no.161001, s/n: (b)(6), sw 3.0.3) experienced technical fault (tf) tf785003 (pm channel observation failed).Investigation showed that no technical faults or technical events were recorded on the reported event date, 25-sep-2025.Review of the available logs identified repeated occurrences of tf785003 and tf444004 (voltage out of tolerance) on other dates.The investigation identified a voltage out-of-tolerance condition associated with the driver board as the most probable cause of the recorded technical faults.No patient involvement, harm, or medical intervention was reported.As correction, the driver board was replaced, and all applicable tests were completed successfully.Based on the investigation results, hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• 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: 50895478
• Report Number: 3001421318-2026-00600
• Device Sequence Number: 20309274
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)201015(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 161001
• Device Catalogue Number: 161001
• 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: 09/06/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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