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

Model Number	951001
Medical Device Problem Codes	Break (1069); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Event or Problem Description
Hamilton medical received the following incident description: "during routine inspection, it was noticed that the connector part of the intellicuff device was cracked".There is no patient involvement reported.If the same issue were to recur during ventilation, an impact on the patient can not be excluded.Therefore, the case is assessed as reportable.
Additional Manufacturer Narrative
Investigation outcome: the partner informed that during routine inspection been noticed that the cuff connector was broken.No patient involvement.A broken cuff connector was found.Therefore, the device had to be 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: 21966305
• Report Number: 3001421318-2025-00586
• Device Sequence Number: 8503274
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)230926(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: 05/06/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown