BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23446084 · Received November 3, 2025

    Report

    Report Number
    2027454-2025-00199
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 1, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THEIR CHAIR ALARM DOESN'T ALARM CORRECTLY SOMETIMES, AND IT DOESN'T ALARM TO THE MAIN STATION, BUT IT DOES ON THE DOME LIGHTS. THE REPORTER ADDED THAT THIS CAUSED A PATIENT FALL. NO PATIENT INJURY WAS REPORTED, AND NO ADDITIONAL INFORMATION WERE PROVIDED AS THE CUSTOMER REQUESTED THE CASE TO BE CLOSED SO THEY COULD WORK ON IT WITH THEIR INTERNAL IT DEPARTMENT. 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. IN THIS EVENT, THE CUSTOMER DID NOT PROVIDE THE NECESSARY INFORMATION TO DETERMINE THE SEVERITY OF THE REPORTED EVENT. AT THIS TIME, THERE IS NO INDICATION THAT THE REPORTED PATIENT FALL WAS SERIOUS IN NATURE, AND THERE WAS NO REPORT OF REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THEREFORE, THIS EVENT WILL BE ASSESSED AS A NON-SERIOUS. ADDITIONALLY, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME AS NO ADDITIONAL INFORMATION WERE PROVIDED BY THE CUSTOMER. IF ANY ADDITIONAL AND RELEVANT INFORMATION IS RECEIVED, THE CASE WILL BE RE-ASSESSED ACCORDINGLY.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CHAIR ALARM DIDN'T ALARM CORRECTLY. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710105 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown