MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "report fault by end user ¿ ventilator was leaking air, but no message was flashing.Pre-op checks and test lung done without alarms, however, customer would still like this to be checked over.T1 ventilator was working well for 1 hour but prior to leaving itu leaking of air was noted but no changes with the numbers.Before ct was started, t1 vent was playing up again with leaking of air noted again.Again no changes with the numbers and no message flag up.Patient stop ventilating at one point, went bradycardic 45 bpm with bigemenies.Incident date & time - (b)(6) 2025 time ¿ 14:40hrs".No health consequences or impact.No intervention necessary.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.So far no relation to the device has been established.
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: based on the available information, the reported air leak noise and wheezing sound from the expiratory port are most consistent with an intermittent leakage within the breathing circuit or expiratory pathway rather than a ventilator malfunction.The absence of alarms or error messages during the event aligns with known system behaviour, as leakage conditions may not always meet alarm trigger thresholds depending on magnitude and duration.Post-event evaluation by the service engineer, including full service software testing and extended operation, did not reproduce the issue and confirmed that the ventilator met all performance specifications with no detected leaks or technical faults.Therefore, no device-related failure could be verified.The patient¿s transient bradycardia and decrease in blood pressure occurred after switching to the backup ventilator and cannot be directly attributed to a confirmed ventilator malfunction.The most probable root cause remains an intermittent, non-reproducible leak in the external breathing circuit or connections during patient handling/transfer.The complaint is concluded as "no fault found" for the ventilator.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: 23461862
• Report Number: 3001421318-2025-00897
• Device Sequence Number: 10300272
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)190131(240)161006
• 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): 04/27/2026

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: 161006
• Device Catalogue Number: 161006
• Was Device Available for Evaluation?: No
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2019
• 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