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	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description (quotation): "- during inspection, we found that the machine¿s self-test was failing.- we cross-checked the machine with a new control board, after which the machine started working properly and the self-test was completed successfully.- this confirmed that the existing control board was defective.- we replaced the defective control board with a new one.The machine is now working properly, and all tests and calibration procedures were successfully completed.- the machine was handed over to the customer in good working condition." no patient involvement, harm, or medical intervention was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference: (b)(4).Hamilton medical ag¿s conclusion:   it was reported that a hamilton-c1 (product no.161001, s/n: (b)(6) failed the self-test during inspection.No patient involvement, harm, or medical intervention was reported.  investigation showed repeated startup and self-test failures associated with tf444004 (voltage out of tolerance), tf431002 (blower disconnected), and tf446024 (+3v3 error alarm).The investigation indicated that inadequate internal supply voltages associated with the control board were the most probable cause of the reported startup and self-test failure.  the control board was replaced.Following replacement, startup was restored, tf444004 was no longer observed, and blower flow and pressure 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: 50910849
• Report Number: 3001421318-2026-00601
• Device Sequence Number: 12207028
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)210531(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Was Device Available for Evaluation?: No
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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