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	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that during the ventilation of a patient, the device ventilation stopped with the following technical events 231009 (blower controller speed low), 231032 (expiration valve disconnected) and technical faults 431017 (inspiration valve disconnected), 431002 (blower disconnected).No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Hamilton medical ag received the logfiles of the device for analysis.Logfiles analysis show that the device generated the following alarms: 86| on (b)(6) 2026 05:36:53|power |off ventilation software.87| on (b)(6) 2026 05:35:36|!! |technical event:244018 condition removed.88| on (b)(6) 2026 05:35:33|tf |446029, 89| on (b)(6) 2026 05:35:33|tf |1746004, 90| on (b)(6) 2026 05:35:33|tf |431001, 91| on (b)(6) 2026 05:35:33|tf |1446029, 92| on (b)(6) 2026 05:35:32|tf |1485001, 93| on (b)(6) 2026 05:35:32|!!! |technical event:231009 condition removed, 94| on (b)(6) 2026 05:35:31|!!! |technical event:231009, 95| on (b)(6) 2026 05:35:30|!! |technical event:244018.Technical event 244018 - blower voltage out of tolerance.Technical event 231009 - blower controller speed low.Technical fault 431001 - blower fault.Technical fault 446029 - ambient failure.Technical fault 1746004 - panel error.Investigation ongoing.

• 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: 25604782
• Report Number: 3001421318-2026-00390
• Device Sequence Number: 21282638
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)220919(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/24/2026

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: 06/16/2026
• Initial Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 09/19/2022
• 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