BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23610380 · Received November 20, 2025

    Report

    Report Number
    2027454-2025-00222
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN THOROUGHLY INSPECTED THE NURSE CALL DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE NURSE CALL DEVICE FUNCTIONED AS DESIGNED. HOWEVER, IF THE REPORTED EVENT OF A CODE BLUE NOT ALERTING WERE TO RECUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, THEREFORE BAXTER CONSIDERS THIS EVENT REPORTABLE.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE GRS10'S WERE NOT ALARMING THE CODE BLUE. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441510 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.