MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that during invasive ventilation in duopap mode after return of spontaneous circulation, no air reached the patient.The device was stopped immediately, and the patient was manually ventilated with a bag.No harm was reported.No further clinical signs, symptoms or conditions and no health consequences or impact, were reported.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).; hamilton medical ags reference: (b)(4).
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); hamilton medical ags conclusion: it was reported that a patient in rosc (return of spontaneous circulation) was placed on invasive ventilation using a hamilton t1 in duopap mode, and that ventilation appeared insufficient although the settings seemed correct.The hospital indicated that no air was reaching the patient, and the ventilator was replaced at the bedside.The log files showed that the ventilator operated correctly.All internal tests, calibrations, and safety checks were successfully completed, and no device for technical issues or technical malfunctions were recorded.The logs further showed that during the event the pressure settings were changed in such a way that the effective pressure difference between p high and peep was reduced to only 4 mbar.This pressure gradient is insufficient to generate an adequate tidal volume.Test lung simulations confirmed that only approximately 180 ml could be delivered under these conditions.The replacement ventilator was able to ventilate the patient with the same settings, indicating normal device performance.The conclusion is that no device malfunction occurred.The most likely root cause was an incorrect parameter adjustment, specifically increasing peep (and pressure support) instead of increasing p high, resulting in an inadequate pressure difference for effective ventilation.No harm to the patient, user, or third party was reported, although medical intervention was required because the ventilator had to be exchanged.Application specialist from the hospital will train the staff.No further information was received.Case is considered closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 24302799
• Report Number: 3001421318-2026-00059
• Device Sequence Number: 12091805
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)211103(240)1610060
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown