MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that the ventilator is not charging.No health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains the investigation outcome.The ventilator was able to start and operate normally at first, which confirms that the basic system was functional.According to the logfile, the device was switched on (b)(6) 2026.On (b)(6) 2026, it was started in psimv+ mode at 07:44:14.During operation, the ventilator reported several ¿loss of external power¿ and ¿battery low¿ alarms, showing that it was no longer receiving stable mains power and had to run on the internal batteries instead.Because the device did not have reliable external power, the batteries continued to discharge until they were completely empty.This stoppt the ventilation and the device switched to an ambient state at 08:54:47, with tf 444001, which indicates batteries completely discharged.This sequence matches the reported problem that the ventilator was not charging, since the battery level decreased instead of increasing while the device was connected to external power.The most likely cause was a failure in the mains power path, either due to a defective mains power connection or source or a defective internal power supply.As a corrective action, the power supply was replaced and solved the issue.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24494676
• Report Number: 3001421318-2026-00100
• Device Sequence Number: 10684781
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)231101(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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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