MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Event or Problem Description
Hamilton medical ag received the following event description:" while using this c1 on a patient, an alarm suddenly sounded, displaying ¿blower failure,¿ and the ventilator switched to ambient mode.Therefore, the hospital staff immediately replaced the ventilator." no health consequences or impact.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
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24127968
• Report Number: 3001421318-2026-00028
• Device Sequence Number: 10387471
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)250805(240)1610010
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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