MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

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.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4); investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: it was reported that the ventilator did not deliver more than 21 percent oxygen and triggered a ¿low oxygen¿ alarm when the fio2 was set to 30 percent or higher.No device logfiles were provided with the complaint.Based on the information received, no patient was involved, no harm occurred, and no medical intervention was required.The most probable root cause was assessed as a defective o2 mixer assembly, specifically the o2 proportional valve.The local service engineer ordered the o2 mixer assembly, and the replacement part was shipped by hamilton medical inc.(hmi) to the device user.However, no confirmation was received as to whether replacement of the o2 mixer assembly resolved the issue, despite repeated follow up attempts.Due to the absence of further information, the complaint is closed.

• Brand Name: HAMILTON-T1
• 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: 24480937
• Report Number: 3001421318-2026-00096
• Device Sequence Number: 21172438
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)200228(240)161006
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 161006
• 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: 04/14/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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