MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation is ongoing.
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report concerning a neonatal transport during which the infant was ventilated in ncpap mode at 21% oxygen.The infant showed reduced oxygen saturation and shallow breathing, and clinical staff attempted to increase the oxygen concentration to 23% and later to 28%.According to the report, the delivered oxygen did not increase and the ventilator generated an oxygen supply alarm.The same behavior occurred when a different oxygen cylinder was connected.The transport was completed using emergency drive mode.The infant stabilized with gentle stimulation, and no health consequences were reported.Logfile data from 09 march 2026 shows repeated ¿oxygen supply failed¿ alarms following attempts to increase oxygen above 21%.Functional checks performed on 09 march 2026 did not reveal any device errors.No further information was provided yet.The investigation to verify the allegation is still in progress.

• 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: 24603103
• Report Number: 3001421318-2026-00134
• Device Sequence Number: 20974628
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)230331(240)1610060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• 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): 06/10/2026

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
• Was Device Available for Evaluation?: No
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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