MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation outcome: the root cause was found to be "clogged air intake dust filter on nbc filter adapter." uninstalling the nbc option and replacing the hepa filter cover with a normal filter cover and the hepa filter for nbc with a normal hepa filter resolved the issue.All service software tests passed.No further problems have been reported, no additional investigation is deemed necessary at this time.
Event or Problem Description
Hamilton medical ag received the following event description: "customer said vent stopped working and showed "safety ventilation error 8".I searched the log files and found 3 tf codes: 346054, 341009, and 385002.Another vent was brought to the users.Patient was reported to not have any issues while waiting." no health consequences or impact.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 23631584
• Report Number: 3001421318-2025-00924
• Device Sequence Number: 10477744
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)220119(240)161009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• 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): 11/24/2025

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: 161009
• Device Catalogue Number: 161009
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2022
• 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