MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160001
Medical Device Problem Codes	Use of Device Problem (1670); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: (1) detailed complaint and failure description summary: "blower defective alarms along with not performed maintenance issue." (2) no clinical signs, symptoms or conditions.No health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: investigation ongoing.
Additional Manufacturer Narrative
The following was reported "visited and found that ventilator showing self-test failed, blower service required and te231009 (blower speed low) and tf431002." issue occurred during ventilation first time before the reported event day, no patient harm reported.Maintenance not carried out within designated time frame and user ignored "blower service required" and "preventive maintenance required" alarms." correction: blower module replaced and 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: 21100769
• Report Number: 3001421318-2025-00062
• Device Sequence Number: 8935293
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)190218(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: 12/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2019
• 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
• Patient Sex: Unknown