MAUDE Adverse Event Report: HAMILTON MEDICAL AG Breathing circuit set, coaxial

Model Number	260127
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation is ongoing.Hmag reference number: fsca-2026-05-03 fda reference: res 99028.
Event or Problem Description
It was reported to hamilton medical ag, that: on april 27, 2026, the hamilton-t1 ventilator (pn 161006 / sn (b)(6) and the breathing circuit set (pn 260127 / ln 203455) experienced an exhalation obstruction alarm.The patient was not harmed.Patient involvement was reported with medical intervention (replacement of the exhalation valve) was reported.However, no patient, user or third-party harm was reported.

• Brand Name: Breathing circuit set, coaxial
• Common Device Name: Breathing circuit set, coaxial
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25358877
• Report Number: 3001421318-2026-00347
• Device Sequence Number: 15925872
• Product Code: BZO
• UDI-Device Identifier: 07630002802956
• UDI-Public: (01)07630002802956(10)203455(11)20260202(17)20310201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 260127
• Device Catalogue Number: 260127
• Device Lot Number: 203455
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HAMILTON-T1 PN 161006 / SN (B)(6).
• Patient Sex: Unknown