MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Failure to Run on Battery (1466); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is: cer (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: during standby.Batteries discharging while idle on 4/27.Battery low and external power loss alarms.Service required, tf's 444001, 446029, 485001, 785003 alarmed.No power off in logs on 4/27.No patient involvement.
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.
Event or Problem Description
The following was reported to hamilton medical ag: during standby.Batteries discharging while idle on 4/27.Battery low and external power loss alarms.Service required, tf's 444001, 446029, 485001, 785003 alarmed.No power off in logs on 4/27.No patient involvement.
Event or Problem Description
The following was reported to hamiton medical ag: during stgandby.Batteries discharging while idle on 4/27.Battery low and external power loss alarms.Service required, tf's 444001, 446029, 485001, 785003 alarmed.No power off in logs on 4/27.No patient involvement.
Additional Manufacturer Narrative
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.The issue occurred when the device was in standby.No patient involved.The event did not cause or contribute to a death or serious injury to a patient.The root cause of the event was the batteries totally discharged and is consequently a user error, attributed to the lack of necessary user actions.Although the root cause of the event was identified as use error, the incident remains reportable as a potential deterioration in patient's health condition (which did not happen) could not be fully excluded.

• 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: 19575304
• Report Number: 3001421318-2024-01480
• Device Sequence Number: 8410266
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(21)4939(11)230921(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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 05/23/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 11/11/2024; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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