MAUDE Adverse Event Report: HAMILTON MEDICAL AG INTELLICUFF

Model Number	951001
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
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: the device alarmed with tf10 during use.No patient was involved as per provided information.The mention of "during use" is unclear and was questioned but no feedback was received.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Hamilton medical ag received the device logfiles for analysis.All relevant actions, such as operator settings, user interactions, and alarms, are documented in the logfiles.The reported problem occurred during the inspection of the device.It is important to emphasize that no patient was involved at the time of the event.In the provided video, it can be observed that the device generated a tf10 alarm.According to the provided logfile, the device alarmed with disconnection and pressure does not rise (tf10): "143 5 alarm 14211 2000 high alarm: cuff disconnected" "168 5 alarm 19146 3010 tf: pressure does not rise.Tf10 indicates that the motor does not work, pressure cannot be adjusted.Due to the observed pressure problem (tf10 alarm), the intellicuff was replaced with a new one.Hamilton medical ag considers this case closed.
Event or Problem Description
Hamilton medical ag received the following event description: the device alarmed with tf10 during inspection of the device.No patient was involved as per provided information.

• Brand Name: INTELLICUFF
• Common Device Name: INTELLICUFF
• 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: 23641587
• Report Number: 3001421318-2025-00927
• Device Sequence Number: 10149166
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)200904(240)951001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150893
• 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): 01/19/2026

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: 951001
• Device Catalogue Number: 951001
• Was Device Available for Evaluation?: No
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2020
• 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