MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Failure to Sense (1559); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: the hamilton-t1 ventilator (pn 161006 / sn (b)(6) exhibited a 231022 error code during neo therapy.The exact date and time of the event is unknown.This is the second time in x weeks' timeframe that this event occurred.Additionally, it was reported that there was a loss of pressure while running ncpap on a transport flight, with the reported event date of april 26, 2026.Medical intervention was reported, but of unknown nature.Patient involvement with medical intervention (unknown nature), but without patient, user or third-party harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4) investigation is ongoing.Follow-ups will be performed to clarify the nature and details of the reported event as well as to confirm the event date.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25518265
• Report Number: 3001421318-2026-00379
• Device Sequence Number: 9940134
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: 07630002801850
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 161006
• Device Catalogue Number: 161006
• 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: 04/30/2026
• Initial Report FDA Received Date: 06/16/2026
• 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