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	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Logfile analysis confirmed that the device experienced a technical failure during active neonatal ventilation, where a cluster of technical faults (tf446029, tf1746004, tf432001, tf1446029, tf1485001) occurred shortly after ventilation start, leading to transition to ambient state and interruption of ventilation.The device was immediately restarted and ventilation resumed; however, recurrent technical event 232006 was observed during continued operation, followed by a second occurrence of the same fault cluster in standby, after which the device was powered.Historical logs also show repeated occurrence of technical event 232006, including persistence during subsequent startups and a self-test failure on 31-03-2026.Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: the event was reported as a technical event involving blower and mainboard, with high blower temperature reading and ambient failure during ventilation.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 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24798281
• Report Number: 3001421318-2026-00197
• Device Sequence Number: 9944579
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)250129(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): 04/07/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 01/29/2025
• 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