MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Codes	Insufficient Cooling (1130); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hamilton-mr1 ventilator device alerted for ¿fan failure¿.There is no patient involvement.The device log files are provided.The device logfiles shown several technical faults.Even though there was no patient involvement at the time of the reported event, it cannot be excluded that the potential malfunction (if confirmed) would not contribute to death or serious injury if the malfunction (again if confirmed as a user error is not excluded) were to recur.Potentially it is not clear if the user was placing prior to the reported event the ventilator to close to the mri device which would conduct to the reported issue.Investigation is therefore needed.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Final report measures taken: replaced the fan (msp161855) and the fan failure issue was solved.
Additional Manufacturer Narrative
It was reported the device began alarming for "fan failure".Additional information was received that the device was brought close to mri.The tesla spy of the hamilton-mr1 indicates with green, yellow and red light when the device is brought too close to the mri device.If these indicators are disregarded, there can be consequences on the performance of the device.There was no report of patient involvement; harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.Local service engineer identified the fan as the defective component.Replacement of this part resolved the issue.The issue was corrected successfully, and the device was returned to the customer.The case is considered 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: 21924743
• Report Number: 3001421318-2025-00562
• Device Sequence Number: 4059612
• Product Code: CBK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)230208(240)161010
• Combination Product (Y/N): N
• 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): 12/08/2025

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
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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