MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following complaint description (quotation of the customer/reporter): "on (b)(6) 2025, during the operation of the ventilator, the screen and knob malfunctioned, making it impossible to adjust the ventilator parameters.The department immediately stopped using it and reported it to the medical equipment department for repair, replacing it with a similar product to continue treatment." no clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ags reference: hamilton medical ags conclusion: the root cause of the reported touchscreen issue on the hamilton-c3 ventilator was a temporary calibration deviation identified during device startup.The issue was resolved through recalibration, confirming it was maintenance-related and not due to a product defect.No corrective action was required, as the device functioned normally after recalibration.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 21771194
• Report Number: 3001421318-2025-00484
• Device Sequence Number: 8200674
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)210311(240)160005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 160005
• Device Catalogue Number: 160005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown