MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (quotation of the reporter): "end user of the device states that during ventilation, without warning, device went into safety ventilation.Device had to switched out for another." no further 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 ags reference: (b)(4); hamilton medical ags conclusion: it was reported that during ventilation, the hamilton-c6 ventilator switched into safety ventilation without prior warning, and the device was replaced by the end user.The event occurred on july 11, 2025, and the manufacturer became aware on july 14, 2025.Log file analysis showed repeated ¿check flow sensor tubing¿ alarms, followed by sensor failure mode and a high priority alarm ¿external flow sensor failed.¿ safety ventilation was initiated and a safety ventilation alarm was recorded.No ventilation stop occurred, and ambient condition did not occur at any time.The device was operating with software version 2.0.5.The most probable cause but not confirmed is linked software version 2.0.5 used.An update to software version 2.0.7 or higher, currently 2.0.11, is recommended.No patient harm was reported.No confirmation of the software update or the device¿s return to clinical use has been received.Case considered closed.
Additional Manufacturer Narrative
Corrected data: it was mistakenly mentioned hamiltion-c6 in the conclusion wording.The correct affected device is hamilton-c3: it was reported that during ventilation, the hamilton-c3 ventilator switched into safety ventilation without prior warning, and the device was replaced by the end user.The event occurred on july 11, 2025, and the manufacturer became aware on july 14, 2025.Log file analysis showed repeated ¿check flow sensor tubing¿ alarms, followed by sensor failure mode and a high priority alarm ¿external flow sensor failed.¿ safety ventilation was initiated and a safety ventilation alarm was recorded.No ventilation stop occurred, and ambient condition did not occur at any time.The device was operating with software version 2.0.5.The most probable cause but not confirmed is linked software version 2.0.5 used.An update to software version 2.0.7 or higher, currently 2.0.11, is recommended.No patient harm was reported.No confirmation of the software update or the device¿s return to clinical use has been received.Case considered closed.

• 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: 22793414
• Report Number: 3001421318-2025-00750
• Device Sequence Number: 15532491
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)190613(240)160005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/24/2026

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 02/24/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown