MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that during the ventilation of a patient, the device showed a number of alarm messages including ¿safety ventilation, cancelled ventilation¿ and, then ventilator switched off.The ventilator was swapped out with another ventilator.No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains also the investigation outcome.It was reported that during the ventilation of a patient, the device showed a number of alarm messages including ¿safety ventilation, cancelled ventilation¿ and, then ventilator switched off.The ventilator was swapped out with another ventilator.No harm to the patient was reported.The reported event date is 28.03.2026.On the reported event date, the ventilation software was switched on, there was a patient connected to the device for approximately 23 hours and 50 minutes.The device alarmed with "disconnection on patient side", "vt low", "te 231032", "te 246005", "low pressure" and several other alarms.However, on the reported event date, there is no record in the log files indicating that ventilation stopped.Technical event: 231032 - expiration valve disconnected.Technical event: 246005 - alarm monitor defective.The device registered ambient state (tf 446029) on 26.03.2026, not on the reported event date of 28.03.2026.Following the event, the service technician confirmed that the issue could not be reproduced and that no parts were replaced.The device successfully passed all service software checks and was returned to clinical use.Hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• 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: 24829155
• Report Number: 3001421318-2026-00206
• Device Sequence Number: 13051037
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)201016(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201658
• 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): 04/09/2026

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: 160021
• Device Catalogue Number: 160021
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• 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