MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Failure to Interrogate (1332); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: - hamilton medical ag received the following incident description: "at power-up unit alarmed for hardware parameter file read failed".- this occurrence was noticed at start-up during the booting process outside the biomed shop.- there is no patient involvement reported.- there is no need for any medical intervention reported.- neither delay in treatment nor harm to the patient, user or third party has been reported.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: cer (b)(4).Initial report: ------------------------------------------------------------------------------------------.
Additional Manufacturer Narrative
The log files provided confirm the issue.It was reported by the local technician that connections were checked on tesla spy board and everything was connected properly.The tesla spy protection board was removed and powered-up the unit with no issue.The tesla spy protection board was reinstalled and it was possible to power-up the unit with no issue.The power was cycled several times with no issue.Initial install service checks per manufacturer specifications were performed.Unit passed all functional tests.Unit placed into service.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20772447
• Report Number: 3001421318-2024-02771
• Device Sequence Number: 19930545
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)241014(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 1610100
• Device Catalogue Number: 1610100
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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