BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23490698 · Received November 6, 2025

    Report

    Report Number
    2027454-2025-00202
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND IMPROPER CONFIGURATION CHANGES ON SECONDARY MONITORING SETTINGS WHICH WERE MADE BY THE SITE. THE VOALTE NURSE CALL SYSTEM PROVIDES A COMPREHENSIVE COMMUNICATION AND INFORMATION SYSTEM THAT PLACES PATIENT CALLS, STAFF CALLS AS WELL AS EMERGENCY AND CODE CALLS. THE SYSTEM PROVIDES AN ANNUNCIATION OF THESE CALLS AT BOTH ROOM LOCATIONS AND PRIMARY(DEDICATED) NURSE CALL STATIONS. THE VOALTE NURSE CALL SYSTEM ALSO HAS AN OPTION FOR SECONDARY NOTIFICATION CALLS TO CUSTOMERS PROVIDED THIRD-PARTY PRODUCTS (E.G CELL PHONES) WHERE CALLS MAY ALSO BE FORWARDED. THE SECONDARY NOTIFICATION WORKFLOWS ARE OPTIONS OFFERED TO THE FACILITIES THAT THE FACILITY MAY OR MAY NOT CHOOSE TO IMPLEMENT AS AN ADD ON TO THEIR PRIMARY NOTIFICATIONS, DEPENDING ON THEIR FACILITY¿S DESIGN AND NEEDS. THE NURSE CALL SYSTEM SECONDARY NOTIFICATION PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA CUSTOMER DESIGNATED NURSE CALL COMMUNICATION DEVICES. THE LOCATION OF THESE DEVICES CAN BE AT A SPECIFIC CONSOLE IN PBX DEPARTMENT, A STAFF STATION LOCATED IN A BREAK ROOM OR HALLWAY, MOBILE PHONES, ETC. THE CUSTOMER PREFERENCE/REQUEST AT THE TIME OF THE INITIAL INTEGRATION. THE BAXTER TECHNICIAN ARRANGED TO GET THE ROOM CONFIGURED CORRECTLY FOR THE CUSTOMER TO RESOLVE THE ISSUE. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTED EVENT WERE TO RECUR IT COULD LEAD TO INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS COMPLAINT.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE STAFF EMERGENCY TRIGGERED FROM THE ROOM BUT NOT ALARMED. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE STAFF EMERGENCY TRIGGERED FROM THE ROOM BUT NOT ALARMED. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176211 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599 00887761995079

    Patients

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