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	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: the logfile shows repeated alarms ¿high peep¿ and ¿exhalation obstructed¿.Because ¿high peep¿ occurs together with ¿exhalation obstructed¿, the most likely explanation is that the ventilator cannot release pressure normally during expiration.The most probable causes are: an expiratory limb that becomes partially kinked/occluded in certain positions; an expiratory valve set with intermittent sticking (sticky membrane) that occasionally does not open smoothly; a partially blocked bleed/exhaust port; or intermittent obstruction/contamination affecting the flow measurement.The problem could not be reproduced (re-constructed).As a precaution, the expiratory valve cover was replaced.This action reduces risk from cover-related exhaust restriction but does not fully exclude other expiratory-path.
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: 24412457
• Report Number: 3001421318-2026-00083
• Device Sequence Number: 20302965
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)201001(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: 10/01/2020
• 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