MAUDE Adverse Event Report: HAMILTON MEDICAL AG Breathing circuit set, coaxial

Model Number	260168
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation is ongoing.Hmag reference number: fsca-2026-05-03.Fda reference: res 99028.
Event or Problem Description
It was reported to hamilton medical ag, that: on (b)(6) 2026 the hamilton-t1 ventilator (pn 161006 / sn (b)(6) and breathing circuit set (pn unknown / lot unknown) passed pre-use check, but when connected to the patient displays "exhalation obstruction" alarm and cannot ventilate.Patient involvement with medical intervention (natural of medical intervention unknown) was reported.However, no patient, user or third party harm was reported.

• Brand Name: Breathing circuit set, coaxial
• Common Device Name: Breathing circuit set, coaxial
• 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: 25359469
• Report Number: 3001421318-2026-00348
• Device Sequence Number: 13258209
• Product Code: BZO
• UDI-Device Identifier: 07630002802987
• UDI-Public: (01)07630002802987
• 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,Health Professional,User Facility,Distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 260168
• Device Catalogue Number: 260168
• Device Lot Number: 203033
• 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: 05/23/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HAMILTON-T1 (PN 161006 / SN (B)(6)
• Patient Sex: Unknown