MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Failure to Deliver (2338); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4) investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that while removing a patient from a ct scan, the device canceled ventilation, and the event log recorded technical faults 446029 (ambient failure detected), 485001 (ambient failure detected) and 431001 (blower fault).The customer also reported the teslaspy indicator flashed yellow despite the incident occurring in a ct environment (not the mri suite).No patient harm was reported.Currently, the event is under investigation to verify the reported allegations.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.It was reported that while removing a patient from a ct scan, the device canceled ventilation.The event log recorded technical faults 446029 (ambient failure detected) and 431001 (blower fault).No harm to the patient was reported.Hamilton medical ag received the logfiles of the device for analysis.Upon review of the logfiles, the issue reported could be confirmed."check teslaspy communication alarm" and technical faults 446029 (ambient failure detected), 431001 (blower fault), and 485001 (ambient failure detected) were recorded in the logfiles.The customer further reported that the teslaspy indicator flashed yellow despite the event occurring in a ct environment.However, review of the teslaspy log data indicated that no color change occurred.A full preventive maintenance (pm), including electrical safety testing (est), was performed, with no issues identified.Follow-up information indicated a suspected intermittent 24 v supply issue, and replacement of the driver board was recommended.After the driver board was replaced, the device displayed ¿read driver board failed (confirmed via error log),¿.Additionally, during the replacement procedure, the bottom front screw fixing on the right-side cover broke.Due to these issues, the device was returned to hamilton medical ag for service, where the failure was reproducible.Subsequent replacement of the driver board with a new unit from stock successfully resolved the issue.Further investigation of the defective driver board revealed no visible damage.The driver board was integrated into a hamilton-c1 device for testing purposes.During operation, the device was unable to access either the service software or normal startpage, remaining blocked during the start-up phase and displaying the error message ¿read driver board failed.¿.The device was unable to start correctly due to missing or incorrect programming of the driver board electrically erasable programmable read only memory (eeprom).The driver board eeprom was programmed in accordance with the released production specifications.It was an out-of-box failure.During testing, an additional issue was identified with the battery 2.When external power was unplugged and battery 1 was removed, the ventilator shut down.Further investigation determined a defective electronic component within the battery.The battery was removed and replaced with another one.Following replacement, full calibration and functional testing were successfully completed.Electrical safety testing (est) was also performed successfully.The root cause was therefore traced to defective components, based on the findings of the investigation.This 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: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 23786816
• Report Number: 3001421318-2025-00966
• Device Sequence Number: 16064362
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)241204(240)1610100
• 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
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 1610100
• Device Catalogue Number: 1610100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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