MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	1610060
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Hypoventilation (1916); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).Service evaluation found no fault: the device passed all tsw (service software) tests without issues and operated as designed.
Event or Problem Description
Hamilton medical ag received the following event description: "intubated a patient in resus -at first co2 came up and good chest rise with sats 92%.Approx 10 min after clinical staff noticed there was no co2 on monitor, then checked for chest rise and wasn't present.Seems vent not working and they took over manual ventilation and ventilator replaced found ventilation working." 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: it was reported that "following intubation in resus", the device initially showed co2 present with good chest rise and spo2 ~92%.After about 10 minutes, staff noted no co2 on the monitor and no chest rise.The device was believed not to be working; and staff initiated manual ventilation and replaced the ventilator.Three attempts were made to obtain additional information regarding the reported event, but none was provided: -whether the event occurred in an ambulance or hospital, and where the device was positioned between 11:04¿12:30.-the reason for five standby pcv+ transitions in that same interval, and whether the brief interruptions were user-initiated or accidental.(log review shows pcv+ never exceeded 2:29 per run, with a 3-second run at 12:02:57¿12:03:00.) -confirmation of when the device was reported to be operating normally after connection to the patient.The issue was not duplicated.However, it is most probable the device was accidentally switched to standby, causing the "co2 on the monitor and no chest rise." service evaluation found no fault: the device passed all tsw (service software) tests without issues and operated as designed.Complaint is considered as closed.The complaint may be reevaluated if additional information is received.

• 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: 23678011
• Report Number: 3001421318-2025-00939
• Device Sequence Number: 13362562
• Product Code: CBK
• UDI-Device Identifier: 07630002813532
• UDI-Public: (01)07630002813532(11)211116(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): 03/13/2026

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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2021
• 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