MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "the crew completed daily preop checks that morning, which passed.The crew attached the vent to the patient for transport.When it failed the first time, they troubleshot it without success and made a 2nd attempt with the same circuit, which failed again.They then switched to a new circuit and expiratory valve, and it failed again with that 2nd circuit and a new expiratory valve.They also checked and rechecked all connections and ensured that there were no loose connections and that everything was hooked up appropriately.When they got back to base, i facetimed with them and saw the failure.We confirmed settings and connections, and the vent failed.So, they switched to a new circuit and expiratory valve and it failed again.This is the 2nd time that this same vent has been sent back to hamilton for the same issues.No health consequences or impact - no intervention necessary.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: the logfile documents repeated high-priority flow-sensor-related alarms from 31-aug-2025 onward, including ¿check flow sensor tubing,¿ ¿check flow sensor,¿ ¿external flow sensor failed,¿ ¿disconnection on patient side,¿ and repeated entries showing ¿sensor failure mode ventilation initiated,¿ which is consistent with the ventilator¿s defined alarm set for flow-sensor faults.The pattern supports a probable intermittent failure in the external flow-sensor circuit, most likely due to improper sensor connection, kinked or obstructed tubing, moisture/liquid in the sensor path, or a defective qvent flow sensor, with possible further contribution from the pressure-sensing path if recurrence continues after sensor replacement.The reported correction showed the ventilator passed service software and functional testing, and preventive measure the qvent flow sensor was replaced.This case is considered as closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24399546
• Report Number: 3001421318-2026-00081
• Device Sequence Number: 8159336
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)220117(240)161009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (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