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

Model Number	951001
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This event was reported to hamilton medical ag as the cuff pressure tube connector, which is located at the bottom of the intellicuff handheld housing, has been broken off.This causes a leak in the circuit, preventing the pressure from rising.There is no patient involvement reported.A low cuff pressure could lead to inadequate ventilation what makes this event reportable.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Additional Manufacturer Narrative
Investigation outcome: hospital staff identified a broken connection port on the cuff pressure tube when attempting to use the intellicuff device and requested repair.No patient involvement or clinical impact was reported.As correction, the intellicuff unit was replaced, which resolved the issue and restored normal functionality.No further issues have been reported, and the complaint is considered closed based on available information.

• 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: 21619939
• Report Number: 3001421318-2025-00427
• Device Sequence Number: 18270371
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: (01)07630002800839(11)210913(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: 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2021
• 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