MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Codes	Computer Operating System Problem (2898); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: start-up failed (black screen) and the ventilator device alarmed.No patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Additional Manufacturer Narrative
Investigation outcome: it was stated that the display of the device turned black (blackout) not during ventilation.The reported issue cannot be evidenced in attached device logs.On reported date of event the ventilator cannot be evidenced running from attached device logs.It is unknown whether the device was taken close to the mri scanner in standby, however, no 'off ventilation software' entry appeared missing in events log, which is an indicator of sudden shutdown or malfunction in case the device is exposed to magnetic field beyond normal range.No teslaspy logs or error logs were provided.It was confirmed that the issue has been resolved and the device was returned.Details of the steps taken in order to resolve the issue were not provided.This case is considered as closed.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 21322084
• Report Number: 3001421318-2025-00236
• Device Sequence Number: 8129134
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)191030(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 161010
• Device Catalogue Number: 161010
• Was Device Available for Evaluation?: No
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 10/30/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown