MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number (b)(4).This report contains the investigation outcome as well.It was reported to hamilton medical ag: ¿fan failure alarm based on information provided by the hospital¿s biomedical department, the device appears to have been brought too close to the mri magnetic field.¿ it was reported that no health consequences or impact to the patient occurred.Analysis of the device logfiles shows the ventilator generated multiple fan failure alarms, and service required events.Exposure to excessive magnetic field strength, with teslaspy color changes (green to yellow to red) confirming the device was positioned too close to the mri scanner.30.03.2026 16:27:42 !!! service required.30.03.2026 16:27:42 mode standby => (s)cmv+.30.03.2026 16:27:42 control ventilation continued after power failure.30.03.2026 16:27:41 !! fan failure.30.03.2026 16:27:28 power on ventilation software.30.03.2026 16:20:52 mode asv => (s)cmv+.30.03.2026 16:20:38 mode standby => asv.30.03.2026 16:20:04 mode asv => standby.30.03.2026 16:18:48 mode spont => asv.30.03.2026 16:18:03 mode (s)cmv+ => spont.30.03.2026 16:17:40 mode standby => (s)cmv+.30.03.2026 15:45:25 power on ventilation software.30.03.2026 16:26:56 color change green: yellow max field strength: 55.30.03.2026 16:26:57 color change yellow: red max field strength: 128.The fan failure alarms are consistent with electromagnetic interference affecting internal components, which resulted in a system shutdown.The fan was replaced, and full functional verification testing was successfully performed to restore the device to its intended performance.As the minimum required distance to the mri scanner was not maintained in contradiction to the instructions provided in the ifu, the incident is classified as user misuse.This case is considered as closed.
Event or Problem Description
It was reported to hamilton medical ag: ¿fan failure alarm based on information provided by the hospital¿s biomedical department, the device appears to have been brought too close to the mri magnetic field.¿ it was reported that no health consequences or impact to the patient occurred.The device removed from patient and sent to hamilton for repair.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: roxana elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24877643
• Report Number: 3001421318-2026-00215
• Device Sequence Number: 12999868
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)181130(240)161010
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 11/30/2018
• 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