BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLICUFF

    MDR report key: 23629674 · Received November 24, 2025

    Report

    Report Number
    3001421318-2025-00918
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    August 28, 2025
    Report Date
    January 19, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BSK
    UDI-DI
    07630002800839
    PMA / PMN Number
    K150893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER : (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE DEVICE LOGFILES FOR ANALYSIS. ALL RELEVANT ACTIONS, SUCH AS OPERATOR SETTINGS, USER INTERACTIONS, AND ALARMS, ARE DOCUMENTED IN THE LOGFILES. ACCORDING TO THE PROVIDED LOGFILE, THE REPORTED PROBLEM OCCURRED DURING THE INSPECTION OF THE DEVICE. IN THE PROVIDED VIDEO, IT CAN BE OBSERVED THAT THE DEVICE GENERATED A TF10 ALARM. THE LOGFILE SHOWS SEVERAL PRESSURE DOES NOT RISE / DISCONNECTION ALARMS: "168 5 ALARM 56 3010 TF: PRESSURE DOES NOT RISE". "177 5 ALARM 73 3010 TF: PRESSURE DOES NOT RISE". "186 5 ALARM 87 3010 TF: PRESSURE DOES NOT RISE". "196 5 ALARM 57 2000 HIGH ALARM: CUFF DISCONNECTED". TF10 INDICATES THAT THE MOTOR DOES NOT WORK, PRESSURE CANNOT BE ADJUSTED. .IT IS IMPORTANT TO EMPHASIZE THAT NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT. DUE TO THE OBSERVED PRESSURE PROBLEMS AND THE TF10 ALARM, THE INTELLICUFF WAS REPLACED WITH A NEW ONE. HAMILTON MEDICAL AG CONSIDERS THIS CASE CLOSED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING USE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION. THE MENTION OF "DURING USE" IS UNCLEAR AND WAS QUESTIONED BUT NO FEEDBACK WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2748820 INTELLICUFF INTELLICUFF BSK HAMILTON MEDICAL AG 951001 07630002800839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown