BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23256279 · Received October 9, 2025

    Report

    Report Number
    2027454-2025-00177
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 FOUND THE GRS10 WERE NOT CONFIGURED TO MONITOR THE CALLS. THEY ADVISED THE CUSTOMER AND WILL CHANGE THE CONFIGURATION ONCE IT IS APPROVED. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTED ISSUE 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 CODE CALL WAS NOT ALERTING. . THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521065 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown