MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Codes	Unexpected Shutdown (4019); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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: original note from customer "t1 ventilator on a patient going into standby after making a loud noise.This occurred at the oc icu." note on the machine also said sept 7th - alarming low vt and minute volumes, despite passing flow sensor test and leak test.Rt unable to troubleshoot" 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: the customer reported an event involving a loud noise from the ventilator, followed by low tidal volume and minute volume alarms and transition to standby, without reported patient harm.Logfile analysis did not identify any corresponding alarms or technical failures on the reported date of (b)(6)2025, with normal device operation documented around (b)(6)2025.Similar alarm patterns consistent with circuit-related issues were observed later ((b)(6)2025), suggesting a possible discrepancy in the reported event date.The most probable root cause is a transient patient circuit issue (e.G., disconnection, obstruction, or leak), although this cannot be confirmed due to absence of log evidence.The device passed all service tests and was returned to use without recurrence, indicating no device malfunction.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: 23299223
• Report Number: 3001421318-2025-00855
• Device Sequence Number: 17359475
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200814(240)161009
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 161009
• Device Catalogue Number: 161009
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2020
• 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