MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference:(b)(4); hamilton medical ags conclusion: it was reported that o2-related alarms occurred on a hamilton-t1 ventilator during patient care and transport, together with "patient disconnection" errors.No patient, user, or third-party harm and no medical intervention were reported.Log file analysis shows repeated o2-related alarms, including low oxygen, high oxygen, and oxygen supply failed.An oxygen supply failed condition was recorded on (b)(6) 2026 at 13:57:04 and cleared at 13:58:10.In addition, multiple disconnection on patient side alarms were recorded on (b)(6) 2026 during ventilation, each resolving within seconds.The log file data indicates unstable or interrupted oxygen supply during transport and intermittent patient side circuit or interface disconnection.This is supported by the presence of oxygen supply failed and low oxygen alarms in high pressure oxygen (hpo) mode, as well as short duration patient side disconnection alarms.Based on the available information and the results of the investigation, a definitive root cause cannot be determined.The device underwent and completed all required service, functional tests and calibrations to resolve the issue.All tests and calibrations passed.The device was returned to service.The case is considered closed.
Event or Problem Description
Hamilton medical ag received the following event description (quotation): equipment o2 alarm, during patient care and transport, as well as "patient disconnect" errors.There was no report of harm to patient, user or third party.No medical intervention was reported.

• 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: 25347160
• Report Number: 3001421318-2026-00342
• Device Sequence Number: 13293991
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)220208(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/01/2026

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: 05/20/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• 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