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	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag`s comes to the following conclusion: the first log file analysis provided showed, multiple entries of ¿blower service required¿ and ¿self test failed¿ and technical fault 431002 ¿blower disconnected¿ in the logs were recorded between on (b)(6) 2025.In addition, it shows that the blower timer had reached 180%, indicating a likely overdue maintenance condition.Although no entries are available for the reported event date (june 19, 2025), the service technician confirmed on (b)(6) 2025, the issue of the device occurred during ventilation and that the ventilator was replaced on (b)(6) 2025.Investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following description based on the current information of the complaint (summary of the reporter): "ventilator showing blower service required and self test failed." additional device was required.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: the field service technician confirmed that the failure occurred during ventilation and that the patient and additional device was required.No patient harm was reported.The field service technician further informed that the blower module was replaced and that the device passed all required service software checks after the repair.Following completion of the functional tests, the device was returned to use.Based on the available information, the investigation is complete and the case is considered closed.

• 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: 22563284
• Report Number: 3001421318-2025-00705
• Device Sequence Number: 9229091
• Product Code: CBK
• UDI-Device Identifier: 07630002800372
• UDI-Public: (01)07630002800372(11)190215(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): 01/30/2026

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: 07/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown