BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JERON CODE BLUE BUTTON, CALL BELL SYSTEM

    MDR report key: 23582433 · Received November 18, 2025

    Report

    Report Number
    MW5178963
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 13, 2025
    Manufacturer
    JERON ELECTRONIC SYSTEMS INC.
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CODE BLUE OR CALL BELL ALARMED WITHOUT ANYONE ACTIVATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768297 JERON CODE BLUE BUTTON, CALL BELL SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ JERON ELECTRONIC SYSTEMS INC. 7923

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male