MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "(b)(6) called in regards to a hamilton c1 sn (b)(6) which suddenly had a blank/black screen during therapy.Therapy was not interrupted during that time, just the screen remaining blank.Rt 'whacked' the screen and it returned momentarily.Issued request to have field engineer service device and extract logs, sent questionnaire to customer." no health consequences or impact; no intervention necessary.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Based on the serial number, the device used was a hamilton-t1, not as described a hamilton-c1.
Additional Manufacturer Narrative
Investigation outcome: it was reported the device's screen went blank/black during ventilation.The display briefly returned after the respiratory therapist tapped (¿whacked¿) the screen.The device was later pulled from use, and the issue was reproducible off-patient.A field engineer (fe) service request was issued to evaluate the device and extract logs.Therapy continued (no interruption), and there was no report of harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.Dispatched service engineer found the ffc cable from the control board to the front panel board was not fully seated at the front panel board side.The cable was reseated, completed service software tests and general tasks; and the issue was resolved.The device was left in a ready for use condition.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: 23631336
• Report Number: 3001421318-2025-00923
• Device Sequence Number: 13145854
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200623(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): 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: 161009
• Device Catalogue Number: 161009
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2020
• 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