MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1 CONFIGURED

Model Number	1610060
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: ventilator does not exhale more than 21% of o2.When o2 is set to 30% or more, "oxygen supply low" alarm engages.- no patient involvement - no intervention necessary.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Hamilton medical ags conclusion: investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: it was reported that the hamilton-t1 ventilator did not deliver more than 21% oxygen (o2), and when o2 was set to 30% or higher, the device triggered a ¿low oxygen¿ alarm.Based on the available complaint information, no patient was involved and no ventilator replacement or harm was reported.The most probable root cause is a defective o2 mixer assembly, including the proportional valve.An o2 mixer assembly was ordered by the local service engineer and shipped to the device user.However, despite multiple follow up attempts, no confirmation was received regarding whether the replacement resolved the issue.Due to the limited information and the absence of verification of the corrective action, this complaint is being closed.

• Brand Name: HAMILTON-T1 CONFIGURED
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 24480532
• Report Number: 3001421318-2026-00095
• Device Sequence Number: 10308700
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200916(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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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