BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 16681694 · Received April 5, 2023

    Report

    Report Number
    2027454-2023-00030
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 5, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVICARE® NURSE CALL¿ (NNC) SYSTEM IS A COMPREHENSIVE COMMUNICATION AND INFORMATION MANAGEMENT SYSTEM THAT HELPS CAREGIVERS PROVIDE THE BEST POSSIBLE CARE TO PATIENTS IN THE MOST EFFICIENT MANNER. THE SYSTEM FACILITATES COMMUNICATION WITHIN A NURSING UNIT. CAREGIVERS HAVE THE ABILITY TO QUICKLY LOCATE AND COMMUNICATE WITH A FELLOW STAFF MEMBER, AND PATIENTS CAN EASILY COMMUNICATE WITH CAREGIVERS, THE NURSING STATION, OR DIRECTLY TO THEIR PRIMARY CAREGIVER. TROUBLESHOOTING ACTIVITIES PERFORMED BY HILLROM DETERMINED THE PBX CONSOLE WAS NOT SET TO WATCH ALL ROOMS ON 2 MAIN FOR CODE CALLS. TO RESOLVE THE ISSUE, THE PBX CONFIGURATION WAS UPDATED TO WATCH ALL ROOMS ON 2 MAIN. TESTING WAS PERFORMED AFTER CONFIGURATION WAS UPDATED AND CODE CALLS WERE CONFIRMED TO PROPERLY ROUTE TO THE PBX CONSOLE. IN THIS EVENT, NO INJURY OCCURRED AS REPORTED BY THE CUSTOMER. IF A MISSED CODE CALL NOTIFICATION TO THE PBX STATION (SECONDARY LOCATION) WERE TO RECUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. HILLROM IS CAUTIOUSLY REPORTING THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCIDENT WITH THE NURSE CALL SYSTEM IN WHICH A CODE BLUE CALL FROM UNIT 2 MAIN DID NOT ROUTE TO THE PBX STATION. THE OPERATOR CONFIRMED CODE CALLS FROM THIS UNIT WERE PREVIOUSLY WORKING. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108134 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 3.9 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown