MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Event or Problem Description
Hamilton medical ag received the following incident description: "fan failure alarm".There is patient involvement reported.The issue did not result in any patient harm.There was no need for any medical intervention reported.The available information reasonably suggest that the device has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.There we assessed this event as reportable.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Follow-up 1: device evaluation.Hamilton medical ag received the logfiles of the device for analysis.All important actions such as operator settings, actions and alarms, etc.Are documented in the logfiles.The event date was reported as april 21, 2025; however, review of device logs indicates "fan failure" has alarmed intermittently since april 19, 2025.In addition, the device was off between april 20 to april 22.Hmi sent the fan (b)(6) to be replaced by the end customer.Following this, three follow-up attempts were made to verify whether the replacement resolved the reported issue.As of today, no response has been received from the end customer.

• 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: alina valean ; via crusch 8; bonaduz
• MDR Report Key: 22076589
• Report Number: 3001421318-2025-00616
• Device Sequence Number: 21008202
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)210923(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2021
• 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