MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: "during clinical use on an intubated patient, a hamilton transport ventilator initially functioned normally and delivered realistic ventilation parameters after all required pre-use checks, including circuit verification according to updated instructions.Suddenly during patient treatment, the ventilator began delivering abnormally rapid ventilation with very low tidal volumes (approximately 60 ml).This was followed by intermittent apnea periods.The device then continued alternating between rapid ventilation with low tidal volumes and pauses in ventilation.The patient was immediately switched to manual ventilation, and the ventilator was replaced with another hamilton device.The replacement device functioned normally without recurrence of the issue.Subsequent testing of the affected ventilator, including standard functional tests and circuit checks, showed normal performance, and the fault could not be reproduced.The breathing circuit was also replaced.All ventilators in the unit had recently undergone maintenance." patient involvement with medical intervention, but no patient, user or third party harm was reported.
Additional Manufacturer Narrative
Hamiton medical ag reference number: (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
• MDR Report Key: 25703641
• Report Number: 3001421318-2026-00404
• Device Sequence Number: 21250119
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)161213(240)161006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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
• 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: 06/22/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREATHING CIRCUIT SET (PN 260127 / LN 201853); BREATHING CIRCUIT SET (PN 260127 / LN 201853).
• Patient Sex: Unknown