MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following complaint description (quotation of the customer/reporter): "release valve defective/tightness test fails." health impact: none, no patient was involved.
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: a tightness test failure was reported for a hamilton-c2 ventilator.No patient was connected at the time of the event, and no harm occurred to any patient or third party.No medical intervention was required.The field technician reported that the front ambient valve module was replaced and that the device functioned as intended afterward.No further information has been provided.The case is considered closed.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crush; 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch; 8; bonaduz
• MDR Report Key: 21342665
• Report Number: 3001421318-2025-00258
• Device Sequence Number: 18382383
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150626(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121225
• 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): 01/09/2026

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: 160001
• Device Catalogue Number: 160001
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2015
• 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