MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4); investigation is ongoing.
Event or Problem Description
Hamilton medical ag received the following event description (summary): the ventilator was reported to deliver no more than 21 percent oxygen, even when higher oxygen levels were set.When the oxygen setting was increased to 30 percent or more, the alarm ¿oxygen supply low¿ activated.No patient was connected at the time of the event.No patient, user or third party harmed nor a medical intervention (ventilator replacement) was reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Manufacturer narrative: additional information: hamilton medical ags conclusion: it was reported on (b)(6) 2026 that the hamilton t1 ventilator was unable to deliver fio2 above 21% and displayed an ¿oxygen supply low¿ alarm when o2 was set to =30%.No patient was involved.No harm to the patient, user, or third party was reported.No medical intervention was required or reported.No other details were provided.No device logs, screenshots, pictures, or videos were provided to support the reported issue.The issue was rectified after replacing the msp161609 o2 mixer assembly.Case is considered closed.Corrected data: h4: manufacturing date: 17.09.2020; d4:(b)(4).

• 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: 24766259
• Report Number: 3001421318-2026-00189
• Device Sequence Number: 21156998
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200917(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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2026

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: 161009
• Device Catalogue Number: 161009
• 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: 04/18/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown