MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Respiratory Acidosis (2482); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Event or Problem Description
Hamilton medical ag received the following event description: "t1 ventilator that stopped ventilating during transport.The full description of the event from clinical staff is as follows: ¿event occured during paitent transport from msj ed to sph icu.Pt was intubated and ventilated.On arrival to sph the ventilator alarmed "turn flow sensor", ve dropped to 0, and etco2 rose to 80mmhg.Placed ventilator on standby and manually ventilated pt on 15lpm.Etco2 decreased to ~60mmhg.Pt transported from entrance of sph to icu manually ventilated.¿" no health consequences or impact.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.So far no relation to the device has been established.
Additional Manufacturer Narrative
Investigation outcome: complaint description: ¿event occured during paitent transport from msj ed to sph icu.Pt was intubated and ventilated.On arrival to sph the ventilator alarmed "turn flow sensor", ve dropped to 0, and etco2 rose to 80mmhg.Placed ventilator on standby and manually ventilated pt on 15lpm.Etco2 decreased to ~60mmhg.Pt transported from entrance of sph to icu manually ventilated.¿ the available log data does not confirm the reported ¿check flow sensor / tubing¿ messages, a ¿flip the flow sensor¿ indication, an external flow sensor failed alarm, or a switch into sensor failure mode, so the reported event cannot be proven from the stored records.What is clearly visible is that on (b)(6) 2026 the ventilator failed the flow sensor calibration four times before succeeding on the fifth attempt, which indicates an unstable or borderline flow sensor calibration condition at that time.In addition, the pressure sensor gain values are unusually spread (pvent control 995, pvent monitor 997, paw 1011), which suggests the device was not optimally calibrated or a sensor or measurement was drifting.The most likely explanation is a temporary measurement instability caused by an incorrectly connected or impaired flow sensor setup (wrong orientation, reversed/loose connections, kinked tubes, or liquid/condensation) or a pneumatic leak that affects calibration stability.Replacing the expiratory valve assembly is consistent with addressing a leak-related contributor and solved the issue.This case is considered as closed.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24112939
• Report Number: 3001421318-2026-00027
• Device Sequence Number: 9696721
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)160204(240)161006
• 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): 03/03/2026

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: 161006
• Device Catalogue Number: 161006
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2016
• 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