MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that during patient transport from the ambulance hamilton-t1 to the hospital hamilton-t1, the user reported that the ventilator was not delivering breaths and that no waveforms or volume/min values were displayed.The patient was manually bagged to facilitate oxygenation.Another ventilator was used.The patient was ventilated in pressure/simv mode on the replacement ventilator.The patient¿s oxygen saturation decreased to 85% and subsequently increased to 93% following manual bagging.Note: hamilton medical ag¿s investigation is ongoing to verify the allegation reported in the complaint.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); investigation is ongoing.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 50893915
• Report Number: 3001421318-2026-00597
• Device Sequence Number: 12238466
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)170810(240)161006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 161006
• Device Catalogue Number: 161006
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown