MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "no delivery of gases during high flow o2 therapy.Measured gas delivery displayed on screen reads between 0.0 lpm and 0.3lpm.Device does not alarm or indicate that there is issue with gas delivery." - no health consequences or impact.No intervention necessary.
Additional Manufacturer Narrative
Hamilton medical ag ref (b)(4).Investigation outcome: it was reported there was no delivery of gases during high flow o2 therapy.Measured gas delivery displayed on screen reads between 0.0 lpm and 0.3lpm.Device did not alarm or indicate that there was issue with the "gas delivery".There was no report of patient involvement; harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.The device logs shows that the device was switched on and that an attempt was made to start therapy in hiflowo2, which matches what was reported.After hiflowo2 was selected, the device repeatedly switched between hiflowo2 and standby, indicating that hiflowo2 operation was being started but could not be kept stable, either because the start conditions were not met continuously or because the device immediately transitioned back to standby.It was advised to perform full service software and verify device operation.However, no further information was received.This case is considered as closed.If further information is received that changes this assessment, a follow-up report will be submitted.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24755625
• Report Number: 3001421318-2026-00180
• Device Sequence Number: 9101001
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)210520(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 03/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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