MAUDE Adverse Event Report: HAMILTON MEDICAL AG BREATHING CIRCUIT SET

Model Number	260127
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: the customer has experienced intermittent issues with certain breathing circuit sets (pn 260127 / ln 202096) used in their cardio pulmonary department.Circuits associated with these events were returned to the biomedical engineering (biomed) department for evaluation.Upon testing, the ventilators passed functional checks; therefore, the customer initiated tracking of circuit lot numbers to identify any common factors.Lot number 202096 was identified as the common factor among the affected circuits.When these circuits were evaluated, the exhalation valve consistently generated obstruction alerts, a condition that was reproduced on three separate ventilators, with the same alert occurring each time, indicating a recurring issue associated with the circuits.Patient involvement with no medical intervention and no patient, user or third party harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation is ongoing.Hmag reference number: fsca-2026-05-03.Fda reference: res 99028.

• 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: 25428689
• Report Number: 3001421318-2026-00369
• Device Sequence Number: 18731810
• Product Code: BZO
• UDI-Device Identifier: 07630002802956
• UDI-Public: 07630002802956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 260127
• Device Catalogue Number: 260127
• Device Lot Number: 202096
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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