MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).Investigation outcome: the logfile 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 system immediately transitioned back to standby.Only later in the sequence did the device generate the ¿check for blockage¿ message, which indicates that a flow restriction was detected after the initial hiflowo2 start attempts.Correction: perform full-service software and verified device operation.Based on the given information, the cause could not be established.If further information is received, a follow up report will be submitted.
Event or Problem Description
Hamilton medical ag received the following event description: no flow delivered no alarms raised device acted as if running normally.No patient involvement.No intervention necessary.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.

• 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: 24255958
• Report Number: 3001421318-2026-00049
• Device Sequence Number: 8327209
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)241108(240)1610010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 1610010
• Device Catalogue Number: 1610010
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 11/08/2024
• 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