MAUDE Adverse Event Report: HAMILTON MEDICAL AG INTELLICUFF; INTELLICUFF PRESSURE CONTROLLER

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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description suddenly, the screen began to flash and the power would not turn off.The event occurred while performing post-use operational checks.The log showed that tf10 was recorded three times.No patient involved.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Follow-up 1: device evaluation.Hamilton medical ag received the logfiles of the device for analysis.All important actions such as operator settings, actions and alarms, etc.Are documented in the logfiles.The provided logfile shows the reported problem.It is important to emphasize that no patient was involved at the time of the event.Tf10 indicates that the motor does not work, pressure cannot be adjusted.The device could not operate as the motor did not work and pressure could not be adjusted.The root cause was determined to be due to the motor remaining stationary and not working as specified.As a result, the intellicuff was replaced.

• Brand Name: INTELLICUFF
• Common Device Name: INTELLICUFF PRESSURE CONTROLLER
• 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: 22121550
• Report Number: 3001421318-2025-00634
• Device Sequence Number: 11799558
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)200728(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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 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: 05/20/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2020
• 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