BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23840568 · Received December 18, 2025

    Report

    Report Number
    2027454-2025-00245
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 10, 2025
    Report Date
    March 5, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H11: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE EVENT HISTORY LOG (EHLR) WAS REVIEWED. THE EHLR SHOWED THE BED EXIT CALL DID ANNUNCIATE ON 11/10/2025 13:35:55 AND WAS CANCELLED BY STAFF MEMBER AT 11/10/2025 13:36:20. ALSO, BED EXIT WAS SHOWING AS ARMED AT 11:27:40, AND WAS NOT DISARMED UNTIL AFTER THE EVENT AT 11/10/2025 13:36:57. OBSERVED, THE BED RAILS WERE LIFTED AT 10:23 AND THERE IS NO RECORD OF THEM GOING DOWN UNTIL AFTER THE BED EXIT CALL AT 13:35. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A VOALTE NURSE CALL DID NOT ALARM WHEN THE PATIENT EXITED THE BED AND FELL. ON THE DAY OF THE EVENT THE PATIENT REPORTEDLY FELL BETWEEN 11:00 AND 13:00. THE MEDICAL STAFF HEARD A THUD, IMMEDIATELY WENT TO THE ROOM, AND THE PATIENT WAS FOUND ON THE FLOOR. THE CUSTOMER NOTED THAT THE BED EXIT ALARM WAS TURNED ON; HOWEVER, THE DEVICE ALARM DID NOT SOUND. IT WAS NOTED THAT THE PATIENT SUSTAINED A RIGHT PERIORBITAL HEMATOMA AND A RIGHT KNEE ABRASION. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM FOR CHANGE IN LEVEL OF CARE AND RECEIVED A HEAD COMPUTED TOMOGRAPHY SCAN (CT) AND REQUIRED UNSPECIFIED SUBSEQUENT SURGERY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER NOTED THAT BOTH THE BED AND THE ROOM WERE TESTED BY THEIR BIOMED AFTER THE EVENT AND NO ISSUES WERE NOTED. THE CHRONOS REPORT WAS CHECKED, AND IT WAS NOTED THAT A BED EXIT CALL WAS PLACED AT 13:35. THE BED RAILS WERE LIFTED AT 10:23 AND THERE IS NO RECORD OF THEM GOING DOWN UNTIL AFTER THE BED EXIT CALL AT 13:35. BED EXIT WAS ARMED AT 11:27. THE REPORT THEN SHOWS THE BED EXIT CALL AT 13:35 AND THEN THE SAME CALL CANCELED AND STAFF LOCATING AT 13:36:20 JUST 35 SECONDS AFTER THE BED EXIT CALL. FURTHERMORE, IT WAS NOTED THAT THE CUSTOMER¿S BED EXIT CALL IS NOT SET UP AS AN EMERGENCY STYLE CALL AND IS NOT SET UP TO AUDIBLY TONE AT THE DOME LIGHT FOR THE ALERTING LOCATION. IT IS SET UP TO ONLY ANNUNCIATE AT STAFF STATIONS WHILE THE UNIT IS IN UNATTENDED MODE, THEREFORE, IT WILL ONLY TONE AT THE PRIMARY NURSE CONSOLE UNLESS THE UNIT IS IN UNATTENDED MODE IN WHICH CASE IT WOULD ANNUNCIATE AT ALL STAFF LOCATIONS WITH AN AUDIO STATION. THEREFORE, IF THE STAFF IS NOT MONITORING THE NURSE CONSOLE WHEN THE BED EXIT CALL IS PLACED, IT WOULD BE POSSIBLE TO MISS IT, IF THEY CANNOT HEAR THE BED ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509982 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N NA 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention VERSACARE FRAME