MAUDE Adverse Event Report: Hamilton Medical AG Breathing circuit set, coaxial

Model Number	260127
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hamilton medical ag received the following description: quotation from the reporter: "on friday evening, on (b)(6) 2026, the clinical team was preparing to transport a patient for diagnostic examinations using a hamilton t1 transport ventilator when a previously observed problem recurred.The ventilator failed to ventilate the patient.The issue was detected at the patient's bedside, allowing the situation to be managed with only a minor decrease in oxygen saturation.A leak test and flow sensor test were performed again using the same breathing circuit.Both tests passed without any issues.The ventilator then began alarming for low tidal volume (vt), which was measured at only 70 ml.A volume-controlled ventilation mode was also tested; however, the ventilator was unable to achieve the desired tidal volume with a test lung.Although the tidal volume was set to 560 ml, only 440 ml was delivered, while the airway pressure increased to 33 cmh¿o." the same test was repeated using a new breathing circuit.However, the problem persisted.The patient was treated with another ventilator.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Hmag reference number: (b)(4).Fda reference: res 99028.Investigation ongoing.

• 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: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 50156342
• Report Number: 3001421318-2026-00477
• Device Sequence Number: 10572052
• Product Code: BZO
• UDI-Device Identifier: 07630002802956
• UDI-Public: (01)07630002802956(10)203516(11)260217(17)310216(240)260127
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Remedial Action: Other,Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 260127
• Device Catalogue Number: 260127
• Device Lot Number: 203516
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 02/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown