MAUDE Adverse Event Report: HAMILTON MEDICAL AG BREATHING CIRCUIT SET

Model Number	260128
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation is ongoing.
Event or Problem Description
It was reported to hamilton medical ag, that: "as per the doctors report: "the alarm was of "low minute/tidal volume" (tv ~60mls), despite good driving pressure.I observed for about 3-4 breaths there was no improvement and so i went back onto the bedside vent.From what i can remember there was not a specific "exhalation obstructed" alarm.We tried again, and the same things happened.I then changed the expiratory filter, and on transferring to the hamilton for the 3rd time there were no issues" patient involvement with medical intervention, but no patient, user or third party harm was reported.

• Brand Name: BREATHING CIRCUIT SET
• Common Device Name: BREATHING CIRCUIT SET
• 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: 25548958
• Report Number: 3001421318-2026-00386
• Device Sequence Number: 10751739
• Product Code: BZO
• UDI-Device Identifier: 07630002802963
• UDI-Public: 07630002802963
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 260128
• Device Catalogue Number: 260128
• Device Lot Number: 202500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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