MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "hamilton t1 ventilator sn 10120.The unit has been reported to stop working with black screen for 15 seconds during a patient care episode.Following this 15 seconds it returned working again." 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).Investigation outcome: per review of device logs, the device was in use and switched off on ((b)(6) 2025).During the next power cycle on ((b)(6) 2025) the device frequently showed the low priority alarms ¿loss of external power¿, which indicates a disconnection of the ac power.However, this would not explain the black screen.The device was tested by our partner in australia and they were not able to reproduce customer concern, even after testing the equipment for few days.Device operated normally without any further errors.Case is considered as closed.

• 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: 23669980
• Report Number: 3001421318-2025-00936
• Device Sequence Number: 9881466
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)190130(240)161006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 11/28/2025

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• 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