MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamiton medical ag: fan failure.No further information received.Patient involvement is also unknown.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).
Event or Problem Description
The following was reported to hamiton medical ag: fan failure no further information received.Patient involvement is also unknown.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information.
Additional Manufacturer Narrative
Hamilton medical ag case number is: (b)(4).Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information.Updated fields: b4, d1, d3, d4, g4, g6, h2, h4, h11.Follow-up 2 - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.It was reported that the device generated a "fan failure" alarm.No patient involvement.Consequently, the event did not cause or contribute to a death or serious injury to a patient.The customer did not provide event logs for analysis.A replacement fan was shipped to the customer.No confirmation was received regarding the resolution of the issue.Although the outcome could not be verified, it is assumed that the issue was resolved by replacing the fan, as no further complaints have been reported.
Event or Problem Description
The following was reported to hamiton medical ag: fan failure.No further information received.Patient involvement is also unknown.

• 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 MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19699294
• Report Number: 3001421318-2024-01632
• Device Sequence Number: 20777391
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(21)4864(11)230615(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 06/17/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 11/11/2024; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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