MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: the analysis of the device event log shows repeated alarms for ¿high peep¿ and ¿exhalation obstructed¿ during ventilation.The alarm pattern is consistent with an intermittent restriction in the expiratory pathway.When the patient cannot exhale properly, the pressure at the end of expiration increases, resulting in a high peep alarm.At the same time, the device detects impaired expiratory flow and generates an exhalation obstructed alarm.During technical inspection using the service software, the adult exhalation pressure test failed twice.All other relevant tests, including tubing tightness, flow, pressure, and valve tests, were passed.The repeated failure of the exhalation pressure test indicates an issue specifically within the expiratory valve system.After the expiratory valve cover was replaced, the adult exhalation pressure test passed and all subsequent tests were successful.No further issues were detected.Based on the event log pattern, the failed exhalation pressure tests, and the successful resolution after replacement of the expiratory valve cover, the most probable root cause was a malfunction of the expiratory valve assembly.The replacement of the expiratory valve cover corrected the issue and restored normal device function.No further information received.Case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: the device alarmed with "exhalation obstructed" alarm and "high-peep" during patient ventilation.No health consequences or impact an additional device was required.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24412797
• Report Number: 3001421318-2026-00084
• Device Sequence Number: 13393589
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)201010(240)161009
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/23/2026

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: 161009
• Device Catalogue Number: 161009
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2020
• 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