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	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that a hamilton-t1 ventilator (product no.1610060, s/n (b)(6), sw 3.1.1) repeatedly generated an "exhalation obstruction" alarm on (b)(6) 2026 while connected to a cct (critical care transport) isolette.The issue was reported to have occurred with multiple breathing circuits from different lot numbers, and the most recently affected circuits remained attached to the isolette at the time of reporting.No patient, user, or third-party harm was reported.A medical intervention was indicated; however, no further details were provided.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4); investigation ongoing.

• 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: 50472498
• Report Number: 3001421318-2026-00521
• Device Sequence Number: 18708047
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)230927(240)1610060
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 08/12/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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