MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: according to the complaint description the device alarmed with te 244018.128|2026-03-11 05:29:18|tf |446029 129|2026-03-11 05:29:18|tf |431001 130|2026-03-11 05:29:18|tf |1746004 131|2026-03-11 05:29:18|tf |1446029 132|2026-03-11 05:29:18|tf |1485001 133|2026-03-09 17:23:17|test |temperature cpu ip, max: 53.0°c, avg: 50.7°c tf 431001 = blower fault tf 446029 = ambient failure detected.The patient had to be moved to a different ventilator.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4 0.The report contains also the investigation outcome.Review of the device event log identified tf 431001 blower fault with associated ambient failure and panel-observed technical fault entries.Following the event, the blower flow test failed, with loud noise noted from the blower.The blower was replaced, followed by service software checks in accordance with manufacturer specifications.The unit passed all functional testing and was returned to use.The case is considered closed.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24726804
• Report Number: 3001421318-2026-00167
• Device Sequence Number: 18445153
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)250731(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
• Report Date (Section B): 03/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: 160021
• Device Catalogue Number: 160021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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