BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23415675 · Received October 29, 2025

    Report

    Report Number
    2027454-2025-00197
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAXTER TECHNICIAN FOUND THE POE NEEDED TO BE RESET. 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 POE RESET FOR THE CUSTOMER TO RESOLVE THE ISSUE. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTS 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 FALL RISK CALL WAS NOT COMING ON THE NURSE CALL SYSTEM. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719175 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown