MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report that a patient was ventilated with a hamilton-t1 in niv-st mode on 22.03.2026 between 09:35 and 11:05.The user reported minimal leakage and noted that the patient had a light beard.Approximately 2000 liters of oxygen available in the ambulance were depleted after about 21 minutes.Switching to a reserve oxygen cylinder restored supply.Upon arrival at the hospital, a portable 2-liter oxygen cylinder was connected and was also rapidly depleted.The patient was subsequently handed over to hospital staff without medical intervention.The high-pressure oxygen coupling was reported to be iced, and the user expressed concern that the ventilator may have drawn excessive oxygen.No patient harm or adverse health effects were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: investigation is ongoing.

• Brand Name: HAMILTON-T1
• 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: 24765167
• Report Number: 3001421318-2026-00177
• Device Sequence Number: 10299330
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)240126(240)1610060
• 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): 06/30/2026

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: 1610060
• Device Catalogue Number: 1610060
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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