BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOALTE NURSE CALL

    MDR report key: 23707309 · Received December 3, 2025

    Report

    Report Number
    2027454-2025-00236
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    ILQ
    UDI-DI
    00887761995079
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H11: A REVIEW OF THE DEVICE LOG INDICATED THAT NO STAFF EMERGENCY CALLS WERE PLACED DURING THAT TIME. UPON INSPECTION OF THE DEVICE, IT WAS FOUND THE EMERGENCY SWITCH WAS DIRTY INSIDE CAUSING THE CANCEL BUTTON TO BE STUCK IN; HOWEVER, THE DEVICE IS BEING RETURNED TO BAXTER AND THE INVESTIGATION IS STILL ONGOING. THE INVESTIGATION IS CURRENTLY ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED A HOSPITAL PAGING SYSTEM FAILED AND A PATIENT PASSED AWAY. IN THE EMERGENCY ROOM AN EMERGENCY CALL FAILED WITH A PATIENT ALLEGEDLY REQUIRING ¿EXTRICATION FROM THE CAR AND BEGINNING ADVANCED LIFE SUPPORT WAS DELAYED¿. THE CUSTOMER STATED, ¿THE PATIENT IS DECEASED, AND THEY CANNOT STATE IF IT WAS DUE TO THE DELAY¿. THE AMOUNT OF TIME THAT THE CARE WAS ¿DELAYED¿ WAS NOT PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2829041 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ BAXTER HEALTHCARE CORPORATION P2599N NA 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NI.