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

Model Number	260167
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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that a ventilator displayed recurring ¿exhalation obstructed¿ alarms during patient ventilation.The device had passed the tightness test and flow sensor calibration prior to use, and a new breathing set was installed.The alarms occurred shortly after the start of ventilation and intermittently during operation on two consecutive days.Ventilation continued, and no patient harm was reported, no additional device required reported.The customer requested clarification regarding the alarms.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: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24674335
• Report Number: 3001421318-2026-00155
• Device Sequence Number: 10144932
• Product Code: BZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• 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): 03/19/2026

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
• Device Catalogue Number: 260167
• Device Lot Number: 203019
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 06/17/2026; 06/17/2026; 09/14/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/17/2026; 06/17/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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