BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOALTE NURSE CALL

    MDR report key: 15696259 · Received October 29, 2022

    Report

    Report Number
    2027454-2022-00023
    Event Type
    Death
    Date Received
    October 29, 2022
    Report Date
    October 28, 2022
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A CODE BLUE ALERT DID NOT ENUNCIATE IN THE FACILITY'S PBX OFFICE FOR THE FACILITY'S 2E UNIT AND THE PATIENT SUBSEQUENTLY EXPIRED. THE CUSTOMER REPORTED THAT THE CODE CALL WAS ENUNCIATED AT THE NURSE'S STATION (PRIMARY NOTIFICATION LOCATION) AND WAS ATTENDED TO, HOWEVER IT WAS NOT RECEIVED AT THE PBX. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT INCLUDING THE DETERMINED CAUSE OF DEATH, THE PATIENT'S MEDICAL HISTORY, WHETHER A DELAY OF CARE OCCURRED, ETC. WERE UNSUCCESSFUL. THE VOALTE NURSE CALL SYSTEM PROVIDES A COMPREHENSIVE COMMUNICATION AND INFORMATION SYSTEM THAT PLACES PATIENT CALLS, STAFF CALLS AS WELL AS EMERGENCY AND CODE BLUE CALLS. THE SYSTEM PROVIDES AN ANNUNCIATION OF THESE CALLS AT BOTH ROOM LOCATIONS AND PRIMARY (DEDICATED) NURSE CALL STATIONS. IN ADDITION, THE NURSE CALL SYSTEM OFFERS THE OPTION TO CONFIGURE SECONDARY NOTIFICATION OF CALLS TO ADDITIONAL LOCATIONS WITHIN THE SYSTEM. THE NURSE CALL SYSTEM SECONDARY NOTIFICATION OPTIONS INCLUDE PROVIDING VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA CUSTOMER-DESIGNATED NURSE CALL COMMUNICATION DEVICES. THE LOCATION OF THESE DEVICES CAN BE AT A SPECIFIC LOCATION OR LOCATIONS WITHIN THE FACILITY SUCH AS A NURSE CONSOLE LOCATED ON A NURSING-SPECIFIC UNIT, A NURSE CONSOLE IN THE PBX DEPARTMENT, A STAFF STATION LOCATED IN A BREAK ROOM OR HALLWAY, MOBILE PHONES, ETC. THE NOTIFICATION ROUTING OF CALLS IS CONFIGURED WITH THE NAMING CONVENTION, AND AUDIO AND /OR VISUAL DISPLAYS BASED ON THE CUSTOMER'S PREFERENCE/REQUEST AT THE TIME OF INITIAL INTEGRATION. A REVIEW OF THE CALL REPORT LOGS INDICATES THAT A CAREGIVER WAS PRESENT IN THE PATIENT'S ROOM AT THE TIME THE CALL WAS PLACED AND THAT MULTIPLE STAFF ENTERED AND EXITED THE PATIENT'S ROOM IMMEDIATELY AFTER AND FOR THE 27-MINUTE DURATION OF THIS CALL. INVESTIGATION AT THE TIME OF THE CUSTOMER CALL BY THE HILLROM TECHNICAL SERVICE DETERMINED UPON ACCESSING THE FACILITY'S SYSTEM CONFIGURATION, IN THE SECONDARY CONFIGURATIONS THE PBX WAS NOT CONFIGURED TO RECEIVE CODE CALLS FOR THE FOLLOWING UNITS 2E AS WELL AS 6J, 6K, AND 1J. THE CONFIGURATIONS WERE CHANGED TO INCLUDE THE PBX OPERATOR IN THE RECEIPT OF NOTIFICATION. AT THIS TIME, IT IS UNKNOWN IF THE ALERT ROUTING/ENUNCIATION CONFIGURATIONS WERE THE EXPECTATIONS OF THE CUSTOMER AT THE TIME OF INITIAL INTEGRATION/CONFIGURATION. ADDITIONAL EVALUATION INDICATED AT THE TIME OF THIS INSTALLATION, A ROOM-BY-ROOM CERTIFICATION WAS PERFORMED CONFIRMING PROPER CALL ROUTING AND ENUNCIATION FOR THIS ASSOCIATED UNIT AND THE CUSTOMER APPROVED THE CALL CONFIGURATION AT THAT TIME. ADDITIONALLY, IT IS NOTED THAT THE CUSTOMER RECENTLY PERFORMED FACILITY RENOVATIONS WHICH INCLUDE THE FLOOR LOCATION OF THIS UNIT, RENOVATIONS WERE NOTED TO INVOLVE DISABLING ROOMS, MOVING UNIT EQUIPMENT, RENAMING ROOMS, AND REQUESTING CALL ROUTING CHANGES INCLUDING ROUTING TO SECONDARY CONSOLES. LOG FILES SHOW THAT STAFF WAS IN THE ROOM AT THE TIME OF THE CODE BLUE CALL AND FOR THE DURATION OF THE CALL, HOWEVER, DUE TO THE INABILITY TO EXCLUDE IF THERE WAS A DELAY IN CARE FROM A SPECIALIZED TEAM THAT POTENTIALLY CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH, THIS IS DETERMINED TO BE A REPORTABLE DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CODE BLUE ALERT DID NOT ENUNCIATE IN THE FACILITY'S PBX OFFICE FOR THE FACILITY'S 2E UNIT AND THE PATIENT SUBSEQUENTLY EXPIRED. THE CUSTOMER REPORTED THAT THE CODE CALL WAS ENUNCIATED AT THE NURSE'S STATION (PRIMARY NOTIFICATION LOCATION) AND WAS ATTENDED TO, HOWEVER IT WAS NOT RECEIVED AT THE PBX. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2795433 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 4.0 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death