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

Model Number	260168
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "ventilator passed pre-op checks, put on patient.Alarm evident "exhalation obstruction - low minute volume".Staff changed patient to different vent (drager v800).Patient ventilated ok.Retrieved spare t1 ventilator, passed pre-op, transferred patient to this t1 ok.Staff checked first t1 (27551) again, put on a test lung.Initially didn't ventilate properly but resolved after 5 minutes and ventilated ok." no health consequences or impact.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (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: 24728855
• Report Number: 3001421318-2026-00171
• Device Sequence Number: 16000462
• 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): 09/16/2026

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: 260168
• Device Catalogue Number: 260168
• Device Lot Number: 27551
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 09/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/26/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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