MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026 the hamilton-c1 ventilator with sn (b)(6) switched from volume control mode to pressure control mode-set rate not being delivered, alarms not where they were previously set.Patient involvement was reported.However, no medical intervention and no patient impact was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).The imdrf annex a code chosen is a0723 - unexpected mode switch.However, this code cannot be chosen in the system.Therefore, the code "4076 - device in backup-mode" was selected.This report also includes the investigation results: analysis of the log files for hamilton-c1 ventilator with serial number (sn) (b)(6) confirmed the ventilation mode switching from (s)cmv+ (volume controlled) to pcv+ (pressure controlled) on the reported event date of january 26, 2026.Further on, it was recorded that the first ventilation mode switching from (s)cmv+ (volume controlled) to pcv+ (pressure controlled) occurred on (b)(6) 2026.Additionally, multiple alarms and errors: high minute volume, vt high, check co2 airway adapter, inspiratory volume limitation, petco2 high, disconnection on patient side, maximum leak compensation - occurred until 'external flow sensor failed' alarm appeared.(b)(6) 2016|2026, 09:02:43|mode |pcv+ => (s)cmv+, (b)(6) 2017|2026, 09:02:43|mode |sensor failure mode ventilation ended, (b)(6) 2018|2026, 09:02:43|!!! |external flow sensor failed condition removed, (b)(6) 2019|2026, 09:02:43|!!! |check flow sensor tubing condition removed, (b)(6) 2020|2026 ,09:02:41|!!! |low minute volume condition removed,.(b)(6) 2021|2026, 09:02:40|!! |vt low condition removed therefore, the device switching to pcv+ (pressure controlled) is expected if the device detects issues in the flow sensor measurement.It was confirmed that full functional tests, software test and electrical safety tests have been performed and all tests passed.Hence, device operates as its intended performance and returned to service.The case is considered as 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: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24925350
• Report Number: 3001421318-2026-00220
• Device Sequence Number: 13078224
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)200929(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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