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

Model Number	951001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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 the user reported that the device alarmed with ¿cuff leak¿ and "check intellicuff" during the ventilation of a patient.This intellicuff was incorporated into hamilton-c6.The use of intellicuff incorporated in this c6 was discontinued, and treatment was continued using a stand-alone type of intellicuff.No harm to the patient was reported.
Additional Manufacturer Narrative
Investigation outcome.The intellicuff integrated in a hamilton-c6 was reported to frequently generate ¿cuff leak¿ and ¿check intellicuff¿ alarms during use.Patient involvement was reported; however, no harm to the patient was reported.As a correction, the intellicuff kit was replaced.After it was installed it in hamilton-c6, a functional verification using test service software was preformed and was returned to the hospital.The 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: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 22191920
• Report Number: 3001421318-2025-00651
• Device Sequence Number: 20980882
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)230207(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): 03/25/2026

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: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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