MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the device failed to charge battery and does not work on ac power.It does not show any indication of ac power when connected to mains.On reviewing the device logs, it was observed that the device was running on battery power since (b)(6) 2026.On (b)(6) 2026 the device alarmed for battery low and later switched into ambient (tf444001).According to the log files the event occurred during ventilation.Although, a patient was involved, no harm occurred and no medical intervention was necessary.The root cause of the event was determined to be a defective power supply.After replacing the power supply the device passed all test and was released for use.No further problems have been reported, no additional investigation is deemed necessary at this time.This case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: unit is not working with mains.No charging indication.- no patient involvement - no intervention necessary.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: ann franz ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25241277
• Report Number: 3001421318-2026-00319
• Device Sequence Number: 9725039
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: 07630002800747
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 161001
• Device Catalogue Number: 161001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/21/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown