MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1 GRAY

Model Number	161009
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report stating that during patient transport a hamilton-t1 ventilator produced a constant high-pitched alarm sound, the display froze, and ventilation stopped.According to the customer, neither the touchscreen nor the hardware controls responded, and the device was restarted by a hard shutdown, after which ventilation resumed normally.No additional device was required.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
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 a hamilton-t1 ventilator emitted a continuous high pitched alarm during patient transport, the screen froze, and ventilation stopped.The touchscreen and p&t (press and turn) knob were unresponsive until the staff performed a hard reset.After restarting, the ventilator operated normally.It was later confirmed that safety ventilation had been activated.No ambient state occurred.No harm to the patient, user, or third party was reported.During inspection, similar alarm conditions could only be reproduced by intentionally disturbing the external flow sensor tubing, such as disconnecting, bending, or obstructing it.The log data did not show evidence of a pressure sensor hardware problem; the dominant pattern indicated disturbances of the external flow sensor.As a precaution, the pressure sensor assembly was replaced.All service tests were passed, and no persistent defect was identified.Based on the available information, the most likely cause is a brief disturbance of the external flow sensor tubing during transport, leading to a chain of sensor events and a temporary firmware deadlock.This cause cannot be proven conclusively.The case is closed based on the current evidence and will continue to be monitored.Case is considered closed.Note: imdrf code in a in this case is a0723 - unexpected mode switch; but this term was not available in imdrf selection of the medwatch at the time of the report.

• Brand Name: HAMILTON-T1 GRAY
• 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: 24362962
• Report Number: 3001421318-2026-00075
• Device Sequence Number: 18692198
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)220214(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): 03/20/2026

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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2022
• 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