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

Model Number	951001
Medical Device Problem Codes	Decrease in Pressure (1490); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4) initial report.
Event or Problem Description
Hamilton medical ag received the following incident description: "the intellicuff device was connected to a hamilton-c6 ventilator device.During patient ventilation the messages ¿check intellicuff state¿ and ¿check intellicuff¿ frequently appeared on the display of the hamilton-c6 ventilator device¿.Medical intervention performed by replacing the intellicuff device and the ventilator device.The issue did not result in any patient harm but if it were to recur an impact on patient could not be excluded.Therefore, this event is assessed as reportable.
Additional Manufacturer Narrative
Investigation outcome: due to the defective motor of the intellicuff, the device and the hamilton-c6 alarms with several alarms which can be found in the logfile and analysis.The event occurred with patient¿s involvement but no health consequences or impact occurred.To resolve the failure, the intellicuff was replaced.No further information was given.This case is considered as closed.

• 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: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 21961002
• Report Number: 3001421318-2025-00582
• Device Sequence Number: 13060940
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)210203(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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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