MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610009
Medical Device Problem Codes	Communication or Transmission Problem (2896); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: "device showed up te231013 while ventilating a patient on the plane (rega)".Intervention was necessary and the ventilator was changed for another one.Hamilton medical ag addition: a first review of the log files showed that the te231013 occurred already during self test prior to usage of the device on patient.Further information/clarification has been requested.
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).A first review of the log files showed that the te231013 occurred already during self test prior to usage of the device on patient.Further information/clarification has been requested.
Additional Manufacturer Narrative
Investigation outcome: it was reported that device alarmed for technical event: 231013 (qo2 sensor defect) during startup, and the device was replaced before patient ventilation.The qo2 sensor was found disconnected.The qo2 sensor was reconnected to resolve the issue.All service software tests and general tasks passed and the device was returned to the customer.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 mueller ; via crusch 8; bonaduz
• MDR Report Key: 22858032
• Report Number: 3001421318-2025-00760
• Device Sequence Number: 9230832
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)141209(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): 03/10/2026

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: 1610009
• Device Catalogue Number: 1610009
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown