MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: (1) detailed complaint and failure description: "function keys are not working".(2) health impact: no health consequences or impact and no clinical signs, symptoms or conditions, were reported.
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: investigation ongoing.
Additional Manufacturer Narrative
It was reported that the hard keys were not working on the device during ventilation of a patient.The patient was moved to another device.No harm to the patient was reported.The event did not cause or contribute to a death or serious injury to a patient.The root cause of the event was determined to be a defective ffc (flat flexible cable) and display front complete.After replacing the ffc (flat flexible cable) and display front complete, the device was released back into use.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; CH 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 21176992
• Report Number: 3001421318-2025-00136
• Device Sequence Number: 18300314
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150626(240)160001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/03/2025

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: 160001
• Device Catalogue Number: 160001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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