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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.(b)(4).Hamilton medical ags conclusion: it was reported that the device generated repeated exhalation obstruction alarms during ventilation, sometimes together with high or low tidal volume alarms.The logfile shows repeated ¿exhalation obstructed¿ alarms over a long period, often occurring in rapid succession and sometimes accompanied by high or low tidal volume alarms.These events happened in different ventilation modes, which indicates that the issue was not mode-specific but related to the expiratory phase of breathing.The high frequency and persistence of the obstruction alarms strongly suggest a mechanical problem in the expiratory pathway rather than a patient-related or setting-related cause.Among the suspected causes, an occluded expiratory limb or a malfunction of the expiratory valve set, such as a sticky membrane or defective proportional valve, is most consistent with the alarm pattern.After the expiratory valve assembly was replaced, the root cause can be concluded to have been a faulty expiratory valve assembly.The defective valve likely impaired proper gas outflow, triggering continuous exhalation obstruction alarms and unstable tidal volumes.Therefore, the root cause of the malfunction was a defective expiratory valve assembly, which was successfully resolved by replacement.Case is considered closed.Udi: (b)(4).
Event or Problem Description
Hamilton medical ag received a report stating that during ventilation the device generated an exhalation obstruction alarm together with vt high and inspiratory volume limitation.The hospital¿s biomed department confirmed that the same issue had occurred previously with this device.The manufacturer requested clarification regarding the use of humidifiers or filters.Biomed later confirmed that filters were installed on both the inspiratory and expiratory side.No health consequences occurred and no clinical intervention 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: 24530317
• Report Number: 3001421318-2026-00110
• Device Sequence Number: 10372137
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)231124(240)1610060
• 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
• Report Date (Section B): 03/06/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/06/2026
• 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