MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation outcome: it was reported that the device failed flow sensor calibration, and logfiles showed ¿check flow sensor tubing¿ errors consistent with a likely disconnected/mis-seated flow sensor or tubing.Additionally, review of device logs shows alarms "external flow sensor failed" and "check flow sensor tubing".The patient was moved to a separate ventilator as a result; however, there was no report of harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.A service technician has checked the device.Service tests have been performed on the device and issue could not be duplicated.General tasks were also successful.Therefore, the device functioned as intended.It was not noted that "flow sensor most likely disconnected" as the most probably root cause.This case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: "flow sensor calibration failure.Logfiles show check flow sensor tubing errors as well.Flow sensor most likely disconnected." no health consequences or impact.Patient moved to separate ventilator.

• 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: 23765434
• Report Number: 3001421318-2025-00958
• Device Sequence Number: 21490642
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)200227(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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 161006
• Device Catalogue Number: 161006
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown