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	04/04/2025
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: "vent began alarming fan failure".There is no patient involvement.The device log files where not provided to hamilton medical.In a worst-case scenario, a fan failure could lead to a deterioration of the state of health of the patient.Therefore, this case was assessed reportable.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Follow-up 1: investigation outcome.According to the complaint description, the device alarmed with "fan failure".It is important to note that no patient was connected to the device at the time of the event.Additionally, the logfiles have not been received for analysis.A replacement fan was provided to the customer to address the reported issue.The shipped fan was replaced, and full-service software tests were performed afterward.Hamilton medical considers this case 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: 21889374
• Report Number: 3001421318-2025-00545
• Device Sequence Number: 17004987
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)200811(240)161010
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• 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