MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON C2; HAMILTON-C2

Model Number	160001
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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): "ventilator shows technical fault technical fault (tf) 431002 (blower disconnect) on startup." health impact: no clinical signs, symptoms or conditions were reported.Problem identified during non-clinical procedure.
Additional Manufacturer Narrative
Additional information: hamilton medical ag`s comes to the following conclusion: the blower module was identified as the defective component.A replacement of the blower module resolved the issue.Corrected: h6 section imdrf codes were updated/corrected.

• 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: 21456753
• Report Number: 3001421318-2025-00337
• Device Sequence Number: 18121054
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)180621(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): 09/18/2025

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: 02/06/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2018
• 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