MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: the nebulizer pressure test failed due to a continuous increase in pressure." no patient involved.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Investigation outcome: it was reported that the pressure continues to rise during the nebulizer pressure test.No patient involvement.The customer has not provided device log files or confirmed the status of the device following replacement.The nebulizer pressure test on the hamilton-t1 ventilator is an internal functional check performed during the ventilator¿s device self-tests.Its purpose is to verify that the nebulizer connection port is sealed properly, confirm that there are no leaks in the nebulizer line or connection and ensure that the ventilator can maintain a stable pressure when the nebulizer path is pressurized.During this test, the ventilator briefly applies pressure to the nebulizer circuit.If the pressure continues to rise beyond the expected limit, the system detects this as an abnormal condition.This test was designed to detect issues before the device is connected to a patient, meaning the ventilator behaved as intended.The reported issue (pressure continuously rising during the nebulizer pressure test) occurred during the hamilton-t1¿s internal functional check.The device correctly identified an abnormal condition and prevented further operation.No patient was connected at the time, and no harm or risk was introduced.As the malfunction was detected by design safeguards during pre-use testing, did not affect ventilation performance, and involved no patient hamilton medical ag has requested further information.However, no further information was received.This case is considered as closed.If further information is received that changes this assessment, a follow-up report will be submitted.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina valean ; via crusch 8; bonaduz
• MDR Report Key: 21592511
• Report Number: 3001421318-2025-00412
• Device Sequence Number: 8220077
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200813(240)161009
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 161009
• Device Catalogue Number: 161009
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 08/13/2020
• 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