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 Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report involving a hamilton-t1 ventilator used during pediatric ventilation.The device was newly prepared with coaxial tubing and tested without issues before patient connection.After the child was connected, the ventilator delivered only a few breaths before generating an ¿exhalation obstructed¿ alarm, resulting in loss of ventilation and patient desaturation.The patient was ventilated with an anaesthesia machine while a new breathing circuit was installed and tested.After reconnection, the same behavior occurred, and ventilation was again lost after only a few breaths.The patient was subsequently manually ventilated during transfer.The error occurred during ventilation, visual and audible alarms were active.No permanent injury was reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: investigation is ongoing.
Additional Manufacturer Narrative
In the initial fda report, field b2 ¿required intervention to prevent permanent impairment/damage (devices)¿ was selected in error.Based on the information available, the clinical interventions performed (transition to an anaesthesia machine and subsequent manual ventilation) were required to maintain ventilation, but they do not meet the fda definition of an intervention performed to prevent permanent impairment or permanent damage.No permanent injury was reported.The incorrect selection has been corrected in this follow-up to ensure accuracy and regulatory compliance.

• Brand Name: BREATHING CIRCUIT SET, COAXIAL
• Common Device Name: Breathing circuit set, coaxial
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: roxana-elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24603584
• Report Number: 3001421318-2026-00136
• Device Sequence Number: 8366606
• Product Code: BZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/07/2026

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: 201208
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/16/2026; Not provided; Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/20/2026; 06/10/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown