MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation is ongoing.
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that a hamilton-c3 ventilator generated technical alerts technical event (te) 231009 (blower speed low) and technical fault (tf) 431002 (blower disconnect) during ventilation.According to the user, the ventilator alarmed repeatedly, and the clinical team switched to a different ventilator.A patient was involved, and no patient harm nor immediate medical intervention was reported.The information received includes the statement that the ventilator ¿stopped working,¿ but this could not be verified, as no log files were available for analysis and the reported alerts do not inherently indicate an immediate interruption of ventilation.Due to the inconsistent information and the absence of objective data to confirm or exclude a therapy-interrupting malfunction, the event is submitted as a conservatively preventive reportable case.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Additional information: hamilton medical ag conclusion: no logfile was provided for this investigation.The hamilton-c3 blower was reportedly sent to the end user by hamilton medical inc.(hmi) usa via return material authorization (rma); however, no confirmation of installation or replacement at the customer site could be obtained.Several attempts were made to contact the service technician to obtain additional information; however, no response was received.Based on the limited information available, a root cause cannot be established.The complaint is therefore closed due to insufficient information.Correction: imdrf coding: annex g has been classified as ¿insufficient information.¿.

• 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: 24825475
• Report Number: 3001421318-2026-00203
• Device Sequence Number: 10220071
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)201112(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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 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: 03/25/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• 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