MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: during ventilation of a patient, the device generated the alarm ¿blower failure.¿ a review of the event logs shows the following technical events and technical failures: 17:36:37 ¿ technical event te 244018: voltage out of tolerance 17:36:38 ¿ technical event te 231009: blower controller speed low 17:36:48 ¿ multiple technical failures recorded including: tf 431001: blower fault tf 446029: ambient state detected.The patient was manually ventilated using a resuscitation bag and subsequently switched to an alternative ventilator.No harm to the patient was reported.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 24880837
• Report Number: 3001421318-2026-00216
• Device Sequence Number: 21294948
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)201103(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: 160021
• Device Catalogue Number: 160021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• 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