MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "device not delivering breath and reaching pressure cap." no health consequences or impact.No intervention necessary.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: the customer reported that the ventilator was not delivering breaths and was reaching the pressure cap during ventilation.Logfile analysis confirms a corresponding event on (b)(6) 2026 (~15:22¿15:42), where the device was operating in (s)cmv+ (pressure-controlled, volume-targeted mode) and repeatedly triggered pressure limitation alarms, preventing further pressure increase to achieve the target tidal volume.As a result, low tidal volume and low minute volume alarms occurred, consistent with the reported ¿not delivering breaths.¿ additional alarms (exhalation obstruction, disconnection) indicate a patient circuit-related issue, most likely increased resistance or obstruction.The device functioned as designed by limiting pressure to the configured maximum, and no technical faults were recorded.The device passed all service tests and was returned to use without recurrence.This case is considered as closed.

• 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: 24276317
• Report Number: 3001421318-2026-00056
• Device Sequence Number: 15526190
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)250730(240)161001
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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