MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: during the ventilation of a patient, when the respiratory technologist was suctioning, the screen when blank and ventilation stopped.No harm to the patient was reported.The patient was bagged until a replacement ventilator was used.Currently, the event is under investigation to verify the reported allegations.
Additional Manufacturer Narrative
Hamilton medical ag`s reference number: (b)(4).Investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag reference: (b)(4).Hamilton medical ags conclusion: following the analysis of the logfiles, no evidence was found to support the reported black screen or ventilation stop.The logs indicate that the device switched between ventilation modes as expected (manually), without interruption.All display connections were inspected and confirmed to be secure.Standard service tests and calibrations were performed, with no errors or irregularities identified.No issues were found during the inspection and testing procedures.The hamilton-c3 was assessed to be fully operational and has been returned to service.No patient harm occurred in relation to the reported incident.The device is functioning within expected parameters.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina valean ; via crusch 8; bonaduz
• MDR Report Key: 21924770
• Report Number: 3001421318-2025-00567
• Device Sequence Number: 14474367
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)201209(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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: 160005
• Device Catalogue Number: 160005
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 10/09/2025
• Date Device Manufactured: 12/09/2020
• 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