MAUDE Adverse Event Report: HAMILTON MEDICAL AG BREATHING CIRCUIT SET

Model Number	260128
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: the customer had a breathing circuit set (pn 260128 / ln 201529) issue where a patient was ventilated appropriately for the majority of their trip, and then a "expiratory occlusion" alarm occurred.The patient had to be bagged for a few minutes before getting to the hospital.No patient harm or change in vitals.Patient involvement with medical intervention (bagging), but without patient, user or third party harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4) investigation is ongoing.Hmag reference number: (b)(4) fda reference: (b)(4).

• 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: 25545613
• Report Number: 3001421318-2026-00384
• Device Sequence Number: 10762627
• Product Code: BZO
• UDI-Device Identifier: 07630002802963
• UDI-Public: 07630002802963
• 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): 06/18/2026

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: 201529
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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