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

Model Number	260167
Medical Device Problem Codes	Increase in Pressure (1491); Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation is ongoing.Note: udi number and all related data to the serial number of the affected hamilton-t1 could not provided with the available information.
Event or Problem Description
Hamilton medical ag received a report that a hamilton-t1 ventilator stopped ventilation or was unable to provide ventilation during a surgical procedure.Testing showed that the diaphragm of the expiratory valve opened only at approximately 20 mbar, preventing proper ventilation.A second similar occurrence involving a breathing set from a different lot had previously been reported.Ventilation was safely maintained using an alternative method, and no harm or health impact occurred.The affected breathing circuit (product number 260167, lot number 203019) was replaced with a new one.The case was reported by the hospital to the local authority (swissmedic, reference (b)(4)).The investigation to verify the allegation is still in progress.

• Brand Name: Breathing circuit set, coaxial
• Common Device Name: Breathing circuit set, coaxial
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: roxana-elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24567789
• Report Number: 3001421318-2026-00123
• Device Sequence Number: 18231566
• Product Code: BZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 260167
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/09/2026; Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/09/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (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