MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: during ventilation of the patient, the hamilton-t1 ventilator device alarmed for peeplow and turn-flow sensor.No device log files are provided to hamilton medical.The ventilator device got exchanged.The issue did not result in any patient harm.The available information reasonably suggest that the device has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event is assessed as reportable.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Additional Manufacturer Narrative
Investigation outcome: it was reported that device alarmed with "turn flow sensor alarms and other issues" during patient ventilation; as a result, the patient was placed on another t1 device.However, there was no report of harm to patient, user or third party, nor a treatment in delay.Questionnaire and additional information requested.Additional information received form partner's completed questionnaire: after the device was removed from the patient, pre op checks were ran, and the tightness test failed each time for a total of 6 attempts.Multiple attempts were made to obtain information regarding the resolution for the reported alarms during patient ventilation, and none were provided.It is also unknown what was done to resolve the repeated tightness test failures after the event.This case is considered as closed.If further information is received that changes this assessment, a follow-up report will be submitted.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 22084337
• Report Number: 3001421318-2025-00621
• Device Sequence Number: 15425180
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200326(240)161009
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: 161009
• Device Catalogue Number: 161009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2020
• 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