MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: "simv not ventilating patient and showing minimal to none vte.Complete failure on patient flight.Simv-tv 450, vte showed 125 with high pips.Pressure mode 18/8, returns low as well because of the lung compliance and unable to ventilate the patient with the vent.He tried smart mode and vte improved but alerts with "asv unable to reach limit".Due to the respiratory patient condition, they tried the vent again on a patient without any respiratory issues and had the same failures.We had this same issue with a vent at delta sn (b)(6) currently being evaluated by your team." patient involvement, but without patient, user or third party harm was reported.
Additional Manufacturer Narrative
(b)(4).Investigation is ongoing.

• 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: 50895312
• Report Number: 3001421318-2026-00599
• Device Sequence Number: 10761851
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)241121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• 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): 09/25/2026

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: 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: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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