BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 17249459 · Received July 3, 2023

    Report

    Report Number
    2027454-2023-00054
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 3, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM VOALTE NURSE CALL SYSTEM PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA DESIGNATED COMMUNICATION DEVICES (NURSES CONSOLE, PATIENT ROOM DOME LIGHTS, MOBILE PHONES (IF APPLICABLE)). NOTIFICATION OF CALLS IS CONFIGURED WITH THE NAMING CONVENTION, AUDIO AND /OR VISUAL DISPLAYS BASED ON THE CUSTOMER PREFERENCE AT THE TIME OF INITIAL INTEGRATION. CONFIGURATION CHANGES MAY ALSO BE PERFORMED BY HILLROM TECHNICAL SUPPORT THEREAFTER UPON RECEIPT OF CUSTOMER REQUEST. IT IS NOTED THAT PRIOR TO THIS EVENT (B)(6) 2023) THE CUSTOMER REQUESTED A NAMING CONVENTION CHANGE FOR THE UNIT ASSOCIATED WITH THE CURRENT COMPLAINT. THE REQUESTED CHANGES WERE MADE BY A HILLROM TECHNICIAN, AND THE CUSTOMER WAS INSTRUCTED TO TEST THE SYSTEM TO VERIFY ALL CHANGES WERE AS REQUESTED. DURING A FOLLOW-UP CALL WITH THE CUSTOMER AT THE TIME OF THE ASSOCIATED CONFIGURATION CHANGES, THE CUSTOMER ¿CONFIRMED THAT THE INFORMATION IS FLOWING CORRECTLY, AND THE CHANGE IS WORKING AS NEEDED.¿ THE CUSTOMER THEN AGREED THE CASE COULD BE CLOSED. AN INVESTIGATION OF THE CURRENT COMPLAINT DETERMINED THAT THE LOCATION NAME CONFIGURATION WAS CHANGED APPROPRIATELY IN THE APPLICATIONS ELECTRONIC CONFIGURATION TOOL, HOWEVER, THE CONFIGURATION OF THE SYSTEM RCBS (ROOM CONTROL BOARDS) WERE NOT UPDATED TO REFLECT THE CHANGE CAUSING THE MISLABELING OF CALLS. IN THIS EVENT, NO INJURY OCCURRED, AS CONFIRMED BY THE CUSTOMER. HOWEVER, IF THE REPORT OF A CODE BLUE ALERT WITH AN INCORRECT NAME OR MISLABEL IN THE SYSTEM WERE TO OCCUR WITH THE PRIMARY CODE BLUE ALERT NOTIFICATION NOT BEING IN THE IMMEDIATE VICINITY, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH THE USE OF THE NURSE CALL SYSTEM, A CODE BLUE ALERTED TO THE APPROPRIATE UNIT LOCATION, HOWEVER, WAS SHOWING THE INCORRECT NAME (5E). THERE WAS NO ALLEGATION OF PATIENT INJURY OR DELAY IN CARE REPORTED FROM THIS ALLEGED INCIDENT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19861 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 3.9 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown