BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOALTE NURSE CALL

    MDR report key: 16627151 · Received March 28, 2023

    Report

    Report Number
    2027454-2023-00022
    Event Type
    Death
    Date Received
    March 28, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 28, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE WITH THE CUSTOMER; HOWEVER, THEY DID NOT PROVIDE ANY FURTHER DETAILS ON THE CHAIN OF EVENTS, MEDICAL TREATMENT PROVIDED, CAUSE, DATE, & TIME OF DEATH, AND THE INDIVIDUAL¿S MEDICAL DIAGNOSIS IMMEDIATELY PRIOR TO DEATH. THE VOALTE NURSE CALL SYSTEM¿PROVIDES A COMPREHENSIVE COMMUNICATION AND INFORMATION SYSTEM THAT PLACES PATIENT CALLS, STAFF CALLS AS WELL AS EMERGENCY AND CODE CALLS. THE SYSTEM PROVIDES ANNUNCIATION OF THESE CALLS AT BOTH ROOM LOCATIONS AND PRIMARY (DEDICATED) NURSE CALL STATIONS. THE VOALTE NURSE CALL SYSTEM ALSO HAS AN OPTION FOR SECONDARY NOTIFICATIONS CALLS TO CUSTOMER PROVIDED THIRD PARTY PRODUCTS (E.G., CELL PHONES) WHERE CALLS MAY ALSO BE FORWARDED. THE SECONDARY NOTIFICATION WORKFLOWS ARE OPTIONS OFFERED TO THE FACILITIES THAT THE FACILITY MAY OR MAY NOT CHOOSE TO IMPLEMENT AS AN ¿ADD ON¿ TO THEIR PRIMARY NOTIFICATIONS, DEPENDING ON THEIR FACILITY¿S DESIGN AND NEEDS. THE NURSE CALL SYSTEM SECONDARY NOTIFICATION PROVIDES 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. INSPECTION OF THE SYSTEM BY A HILLROM TECHNICIAN FOUND THE CODE FAILED DUE TO THE SYSTEM OF A LOST ROOM CONTROL BOARD (RCB). THE FOLLOWING WAS NOTED BY THE TECHNICIAN REGARDING WHERE THE CODE CALL DID NOT ANNUNCIATE: DUE TO THE ROOM HAVING A LOST RCB ALERT, NO CALL COULD ACTIVATE OR ALERT AT THE PRIMARY, SECONDARY OR WIRELESS DEVICES WHILE THIS SYSTEM ALERT WAS PRESENT. ADDITIONALLY, THE DOME LIGHT WOULD NOT BE ABLE TO ILLUMINATE A CALL WHILE THE SYSTEM ALERT WAS PRESENT. THE TECHNICIAN REPORTED THE GRS5 INITIALLY LOST COMMUNICATION TWO DAYS PRIOR TO THE EVENT ON (B)(6) 2023 AT 3:47PM EST. DUE TO THE RCB BEING OFFLINE. THE TECHNICIAN STATES, ¿THE CUSTOMER WOULD HAVE KNOWN THERE WAS AN ISSUE IN THE ROOM ON (B)(6) 2023 AT 3:47PM EST. PER THE CHRONOS REPORT. THIS IS THE TIME THE CHRONOS REPORT SHOWS A ¿LOST RCB¿ CALL. THIS IS A SYSTEM ALERT THAT WILL ALERT AT THE NURSE¿S STATION INDICATING THERE IS PROBLEM IN THE ROOM. THE LOST RCB CALL WILL BE PRESENT AS LONG AS THERE'S AN ISSUE. IT CAN BE PUT ON A WAIT LIST BUT WILL RETURN EVERY 10 MIN UNTIL THE ISSUE IS FIXED. SOMETIMES, ISSUES DO FIX THEMSELVES AND THIS WOULD BE SEEN IN THE CHRONOS REPORT. IN THIS CASE, IT WAS PERSISTENT UNTIL FIXED.¿ ANY DEVICES CONNECTED THAT ATTEMPTED TO TRIGGER A CALL DURING THIS TIME WOULD HAVE NOT BEEN ABLE TO ACTIVATE DUE TO THE RCB BEING OFFLINE. PER THE CUSTOMER'S STATEMENT, THE CALL TRIGGERED WAS A CODE 5 CALL, HOWEVER, PER HILLROM CONFIGURATIONS (ATTACHED VIA THE COMPLAINT), THIS WAS A CODE BLUE CALL. THE SYSTEM IS UNABLE TO CONFIRM WHAT CALL TYPE WAS TRIGGERED DUE TO THE RCB BEING OFFLINE DURING THE TIME OF THE INCIDENT. HILLROM BECAME AWARE OF THE GRS-5 NOT BEING ABLE TO TRIGGER A CALL ON 28FEB282023 AT 7:24AM EST., ONE DAY POST-EVENT. THE CUSTOMER ADDITIONALLY REPORTED AT THIS SAME TIME THAT ROOM 3001 WAS UNABLE TO TRIGGER A CALL AS WELL. THE GRS-5 REGAINED COMMUNICATION ON 28FEB282023 AT APPROXIMATELY 8:50AM. AFTER THE RCB WAS REBOOTED AND CONFIRMED BY THE CUSTOMER MAINTENANCE TEAM THAT THE SYSTEM WAS WORKING/FUNCTIONING AS INTENDED. ADDITIONALLY, THE CUSTOMER CONFIRMED THROUGH TESTING THAT AS OF 01MARCH2023 AT 12:02PM EST., ALL DEVICES IN ROOM 3002 ARE ALERTING CORRECTLY. FOR THIS EVENT, FAILURE OF A CODE BLUE OR CODE 5 OCCURRED WITH PATIENT INVOLVEMENT AND SUBSEQUENT DEATH. INSPECTION FOUND THE CODE BLUE/CODE 5 CALL FAILED TO ANNUNCIATE DUE TO A LOST ROOM CONTROL BOARD (RCB) WHICH SUBSEQUENTLY LED TO AN UNKNOWN REPORTED TIME DELAY IN PATIENT CARE INVOLVING LIFE SUPPORTING MEASURES. IT IS ADDITIONALLY NOTED THAT THE DEVICE MALFUNCTION OCCURRED TWO DAYS PRIOR TO THE EVENT AND THE SYSTEM PROVIDED THE CUSTOMER AN ALERT INDICATING A PROBLEM; THEREFORE, IT CANNOT BE EXCLUDED THAT USE ERROR OF DELAYED REPORTING OF THE MALFUNCTION BY THE CUSTOMER TO HILLROM/BAXTER ADDITIONALLY CONTRIBUTED TO THE EVENT. HILLROM IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSE CALL GRAPHIC ROOM STATION WITH 5¿ SCREEN (GRS-5) DID NOT HAVE POWER. A PATIENT IN ROOM 3002 ¿CALLED THE NURSE AND THE NURSE DID NOT REALIZE¿ (UNSPECIFIED IF THIS WAS A BED PENDANT CALL OR VOCAL CALL TO THE NURSE). THE CUSTOMER REPORTED A ¿CODE 5¿ (EMERGENCY CALL) WAS TRIGGERED AND DID NOT ANNUNCIATE WHICH LED TO AN UNSPECIFIED TIME DELAY IN PATIENT CARE. ONCE THE NURSES ARRIVED IN THE PATIENT ROOM, THEY FOUND THE PATIENT IN ACTIVE CARDIAC ARREST, ATTEMPTED TO RESUSCITATE; HOWEVER, THE PATIENT EXPIRED. IT IS NOTED THE CALL FAILED WITH PRIMARY & SECONDARY CONSOLES, WIRELESS DEVICES, AND THE DOME LIGHT. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13855 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 3.9 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death