MAUDE Adverse Event Report: HAMILTON MEDICAL AG Breathing Circuit Set, Coaxial

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	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description (summary): it was reported that the circuit was attached to a patient following successful pre-operative checks.Upon connecting the patient, the ventilator displayed the error message ¿blocked expiratory valve¿, and no ventilation was delivered.The patient was immediately removed from the circuit and placed back on a bedside ventilator, where ventilation was restored without issues.The circuit was then dismantled, reconnected, and re-checked successfully.However, when attaching the patient a second time, the same issue occurred again.A new ventilator and circuit were obtained.After successful pre-use checks, the patient was connected, and ventilation proceeded normally without further issues.A second incident involved a different patient and a different circuit, but the same ventilator.In this case, the ventilator failed the leak test.The expiratory valve was replaced, the checks were completed successfully, and the device operated normally thereafter.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
The initial udi was incorrect.Corrected, udi to (b)(4).

• 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: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24660440
• Report Number: 3001421318-2026-00154
• Device Sequence Number: 21143054
• 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,Followup
• Report Date (Section B): 09/15/2026

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
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 06/17/2026; 09/15/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/23/2026; 06/17/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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
• Patient Sex: Unknown