MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"ventilator passed pre-op checks, put on patient.Alarm evident "exhalation obstruction - low minute volume".Staff changed patient to different vent (drager v800).Patient ventilated ok.Retrieved spare t1 ventilator, passed pre-op, transferred patient to this t1 ok.Staff checked first t1 (b)(6) again, put on a test lung.Initially didn't ventilate properly but resolved after 5 minutes and ventilated ok." no health consequences or impact.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).
Additional Manufacturer Narrative
Investigation outcome: the customer reported that after a successful pre-operation check, the t1 alarmed with exhalation obstruction and low minute volume on the patient, after which the patient was transferred to another ventilator and ventilated successfully.Log review does not confirm an event on 28-feb-2026; instead, the closest complaint-like alarm clusters occurred on 26-feb-2026, with repeated combinations of exhalation obstructed, low minute volume, vt low, high peep, disconnection on patient side, and inspiratory volume limitation, and a later similar retest sequence on 03-mar-2026 that resolved without logged technical fault.Based on the logs and the t1 manuals, the most probable root cause is a transient expiratory path obstruction, which may have involved the breathing circuit and/or occlusion of the expiratory valve bleed port.No technical fault or persistent internal device error was identified, and the ventilator later passed leak test and calibration checks.The complaint is therefore best assessed as no confirmed device malfunction, with the most probable cause being a transient expiratory obstruction condition.This case is considered as closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24729555
• Report Number: 3001421318-2026-00172
• Device Sequence Number: 10191614
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)231023(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/30/2026

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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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