BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLICUFF

    MDR report key: 21101159 · Received January 8, 2025

    Report

    Report Number
    3001421318-2025-00066
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 8, 2024
    Report Date
    November 23, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BSK
    UDI-DI
    07630002800839
    PMA / PMN Number
    K150893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS REPORTED "THIS INTELLICUFF IS A TYPE THAT IS USED BY BEING INCORPORATED INTO C6. (160784, INTELLICUFF KIT). THE "CUFF LEAK" ALARM STARTED GOING OFF OCCASIONALLY DURING PATIENT USE. DURING THE INVESTIGATION IT WAS ALMOST IMPOSSIBLE TO PRESSURIZE THE CUFF. THERE WAS NO DAMAGE TO THE CONNECTOR PART." PATIENT INVOLVEMENT REPORTED, NO HARM. THE LOGFILES PROVIDED CONFIRM THE ISSUE. INTELLICUFF WAS REPLACED WITH RGA 100853, ISSUE SOLVED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE CUFF LEAK ALARM STARTED GOING OFF OCCASIONALLY DURING PATIENT USE. IT WAS IMPOSSIBLE TO PRESSURIZE THE CUFF.". THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THE DEFECT INTELLICUFF DEVICE WAS REPLACED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106132 INTELLICUFF INTELLICUFF PRESSURE CONTROLLER BSK HAMILTON MEDICAL AG 951001 07630002800839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown