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	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: during the ventilation of a patient, the device displayed the message "ventilation cancelled", after which the screen became blank/black.The ventilator was removed from service, and the patient was subsequently ventilated manually using a resuscitation bag.No harm to the patient was reported.During an onsite visit conducted two days after the event, the service technician successfully retrieved the device log files.A review of the logs identified the occurrence of a monitor disconnect alarm and an expiratory valve disconnect alarm prior to the device transitioning to ambient state.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).The manufacturer has received the logfiles of the device for analysis.Analysis of the available log files did not identify any events corresponding to the complaint description on the reported event date of 01 june 2026.Upon review of the preceding days, it was noted that a female patient had been connected to the device.On 30 may 2026, the following technical failures and technical events were recorded: technical failures.Tf 443001 ¿ watchdog failed lls.Tf 446029 ¿ ambient failure detected.Tf 431017 ¿ inspiration valve disconnected.Technical events.Te 231032 ¿ expiration valve disconnected.Te 246005 ¿ alarm monitor defective.In addition, a disconnection on the patient side was recorded.Investigation ongoing.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): 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: 25423131
• Report Number: 3001421318-2026-00363
• Device Sequence Number: 17639346
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)251201(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/08/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 12/01/2025
• 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