BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23497974 · Received November 7, 2025

    Report

    Report Number
    2027454-2025-00203
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE NURSE CALL SYSTEM PROVIDES A COMPREHENSIVE COMMUNICATION AND INFORMATION SYSTEM THAT PLACES PATIENT CALLS, STAFF CALLS, AS WELL AS EMERGENCY AND CODE BLUE CALLS. THE SYSTEM PROVIDES AN ANNUNCIATION OF THESE CALLS AT ROOM LOCATIONS, PRIMARY(DEDICATED) NURSE CALL STATIONS, AS WELL AS SECONDARY LOCATIONS AND OR DEVICES(PBX OPERATOR, WIRELESS PHONES). THE NURSE CALL SYSTEM SECONDARY NOTIFICATION PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA CUSTOMER-DESIGNATED NURSE CALL COMMUNICATION DEVICES. THE LOCATIONS OF THESE DEVICES CAN BE AT A SPECIFIC LOCATION OR LOCATIONS WITHIN THE FACILITY SUCH AS A NURSE CONSOLE LOCATED ON A NURSING-SPECIFIC UNIT, A NURSE CONSOLE IN THE PBX DEPARTMENT, A STAFF STATION LOCATED IN A BREAK ROOM OR HALLWAY, MOBILE PHONES, ETC. THE NOTIFICATION ROUTING OF CALLS IS CONFIGURED WITH THE NAMING CONVENTION, AND AUDIO AND/OR VISUAL DISPLAYS BASED ON THE CUSTOMERS PREFERENCE/REQUEST AT THE TIME OF THE INITIAL INTEGRATION, OR CAN BE CHANGED THEREAFTER UPON THE CUSTOMERS REQUEST. TROUBLESHOOTING AND INSPECTION FOUND THAT THE NURSE CALL SYSTEM FUNCTIONED AS DESIGNED WITH PROPER ROUTING AND ENUNCIATION OF THE EVENT AT THE ROOM AND UNIT LEVEL. THE CALL WHEN ROUTED TO THE PBX GRS10 CONSOLE DISPLAYED THE CALL WITH VISUAL MESSAGE AND APPLICABLE LIGHT, BUT THERE WAS NO ASSOCIATED TONE. UPON RESETTING THE ASSOCIATED GRS10 DEVICE THE DEVICE FUNCTIONED APPROPRIATELY TO ENUNCIATE THE CALL TYPE WITH VISUAL DISPLAY, LIGHT AND TONE. THE CUSTOMER WAS ALSO PROVIDED A REPLACEMENT GRS10 DEVICE. IN THIS EVENT, NO INJURY OR DELAY IN CARE OCCURRED, AS CONFIRMED BY THE CUSTOMER, WHICH CONCLUDES THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS EVENT. ADDITIONALLY, THE NURSE CALL SYSTEM FUNCTIONS AS DESIGNED TO PROVIDE NOTIFICATION AT THE EVENTS PRIMARY LOCATION. HOWEVER, IT WAS DISCOVERED THAT A FAILURE IN TONE OCCURRED WITH THE PBX GRS10 CONSOLE. IF THE EVENT WERE TO RECUR, FAILURE OF THE TONE OF A CODE CALL NOTIFICATION AT A SECONDARY LOCATION, IT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, AS THE NOTIFICATION WOULD BE DISPLAYED ON THE DEVICES SCREED IN BOLD TYPE AS WELL AS ASSOCIATED DESIGNATED LIGHTS. FURTHERMORE, THE NOTIFICATION WOULD ENUNCIATE (DISPLAY, LIGHTS, TONE) AT THE ASSOCIATED UNIT LOCATION FOR PROMPT RESPONSE BY CAREGIVERS.

    Description of Event or Problem · 0

    THE CUSTOMER INITIALLY REPORTED THAT A NURSE CALL CODE BLUE ALERT DID NOT ENUNCIATE AT THE NURSES STATION. FOLLOW-UP PERFORMED BY BAXTER TECHNICAL SUPPORT CLARIFIED AND CONFIRMED THAT THE ASSOCIATED CODE BLUE CALL DID ENUNCIATE DISPLAY AND TONE APPROPRIATELY AT THE ROOM LEVEL, AND AT THE UNITS NURSES STATION. HOWEVER, THE CALL DISPLAYED BUT DID NOT TONE AT THE SECONDARY NOTIFICATION LOCATION, THE PBX OPERATOR NURSE CALL STATION. THERE WAS AN INITIAL ALLEGATION OF DELAY IN CARE. FURTHER FOLLOW-UP WITH THE ASSOCIATED UNIT CHARGE NURSE CONFIRMED THAT NO INJURY AND NO DELAY IN CARE OCCURRED. THE PATIENT REMAINED UNDER THE CARE OF THE NURSE. FURTHERMORE, THE NURSE STATED THAT CARE DURING A CODE EVENT IS INITIATED AND PERFORMED BY THE CAREGIVERS ON THE UNIT, FURTHER CONFIRMING THAT NO DELAY IN CARE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186553 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N 00887761995079

    Patients

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