MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: customer reports o2 not being delivered by unit.Repeated oxygen supply failed messages.No health consequences or impact no intervention necessary, was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Hamilton medical ags conclusion: it was reported that the ventilator failed to deliver oxygen during ventilation and generated repeated ¿oxygen supply failed¿ alarms.No harm to any patient, user, or third party was reported.No medical intervention.The logs shows the alarms.A complete service software check was performed by the local service engineer, and all functional and performance tests passed successfully.The device operated normally at various fio2 settings, and the issue could not be reproduced (re-constructed).No device malfunction was confirmed.As a precaution, the oxygen quick-connect on the oxygen hose was replaced.The ventilator was verified to be operating within specifications and returned to service.Based on the available information, the case is considered closed.

• 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: 24829273
• Report Number: 3001421318-2026-00205
• Device Sequence Number: 18718427
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)210104(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
• Report Date (Section B): 04/09/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2021
• 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