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	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following complaint description (quotation of the customer/reporter): the complaint has been received as " ambient test failed, after the ambient valve exchange, the device works without any failure." the ambient valve test failed in service software.Health impact: none, no patient involved.
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: additional information: final conclusion: it was found that the ambient valve no longer switches reliably or correctly.The root cause is material fatigue.The affected valve, serial number (b)(6), was delivered on (b)(6) 2013, meaning it has been in operation for over 12 years.The ambient valve was replaced and is back in use without any failure.Corrected and addtional information imdrf codes in section h6 updated.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch, 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch; 8; bonaduz
• MDR Report Key: 21395097
• Report Number: 3001421318-2025-00303
• Device Sequence Number: 8274159
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150629(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): 08/18/2025

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: 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: 02/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2015
• 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