MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: (1) detailed complaint and failure description: "device alarms with high priority technical event: 231009 (alarm blower speed low) due to defective blower.(2) health impact: no clinical signs, symptoms or conditions and no health consequences or impact, were reported.
Additional Manufacturer Narrative
Device alarms with high priority technical event: 231009 (alarm blower speed low) during ventilation of a patient.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 blower module.After replacing the blower module, 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: 21177098
• Report Number: 3001421318-2025-00138
• Device Sequence Number: 4300020
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)150625(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): 11/23/2025

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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• 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