MAUDE Adverse Event Report: Hamilton Medical AG Breathing Circuit Set, Coaxial

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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag, that: "overnight we had an issue with 2 of our hamilton ventilators when attempting to ventilate an intubated patient.The patient bagged well and was reviewed by anaesthetics to assess the ett, there were no identifiable issues with the tube or patient in terms of obstruction.Multiple alarms displaying were "exhalation obstruction" "high peep" "expiratory flow low"." the customer noted that they could not troubleshoot the alarms.They tried two ventilators (sn: (b)(6) & sn: (b)(6) on two different circuits (both part 260128) with no success.Logs show that there are multiple instances of the following alarms: disconnection on patient side, exhalation obstructed & high peep on sn (b)(6).Patient involvement with medical intervention in the form of the patient being bagged and assessment of the ett was reported.However, no patient, user or third party harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation is on-going.Hmag reference number: (b)(4) fda reference: (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 7402 ; SZ 7402
• Manufacturer Contact: jan schaufelberger ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 50814430
• Report Number: 3001421318-2026-00573
• Device Sequence Number: 10680698
• Product Code: BZO
• UDI-Device Identifier: 07630002802963
• UDI-Public: (01)07630002802963(10)202126(11)251027(17)301026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 202126
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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