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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that, during transport of an intubated patient to (b)(6) on (b)(6)2026, a hamilton-t1 (product no.161006, (b)(6), software version not reported) generated an alarm indicating that the oxygen supply was empty approximately 20 minutes before reaching pori.According to the information provided, the transport had started with a full 10-liter oxygen cylinder.The patient was connected to the ventilator without reported difficulty, and no warnings or abnormal device behavior were reportedly observed before the oxygen supply alarm occurred.The transport stopped at a hospital, where the primary oxygen cylinder was replaced with an available spare cylinder.Ventilation was continued using the same hamilton-t1.The complaint records medical intervention as ¿yes¿ and states that ventilation during transport was completed using the spare oxygen cylinder.No patient, user or third-party harm or adverse clinical outcome was reported.The user reported hearing a leak near the plastic retaining nut securing the return hose.According to the user, the expiratory valve had not been fully tightened, and the reported leakage stopped after the expiratory valve was tightened.It was reported that the user or hospital submitted a report to the competent authority.The authority report reference number is currently unknown.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ag¿s investigation is ongoing to verify the allegation reported in the complaint.

• 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: 50930188
• Report Number: 3001421318-2026-00610
• Device Sequence Number: 18516141
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)251002(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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