BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 16761419 · Received April 18, 2023

    Report

    Report Number
    2027454-2023-00034
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 18, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. INSPECTION OF THE SYSTEM VIA A HILLROM TECHNICIAN NOTED THE UNDERLYING ISSUE WAS THAT THE ¿CODE PINK DID NOT ANNUNCIATE ON ALL SECONDARY LOCATIONS, BUT IT DID ON THE SECONDARY (NBN) AND NOT THE NICU (HEYMAN 5TH FLOOR NICU)¿ DUE THE GRS10 BEING OFFLINE AT THE TIME OF THE EVENT. HILLROM LOG FILES (ATTACHED VIA THE COMPLAINT) SHOW THAT THE CALL ROUTED TO A SECONDARY/THIRD PARTY LOCATION (I.E., PBX & MOBILE PHONES, BADGES); HOWEVER DUE TO THE LOST UNIT SERVER NOTHING ANNUNCIATED AT THE NICU. THE GRS10 OFFLINE ISSUE HAS SINCE BEEN RESOLVED AND THE ¿CODE PINK¿ IS NOTED BY THE CUSTOMER TO BE FUNCTIONING AS DESIGNED. FOR THIS EVENT, THE GRS10 WAS OFFLINE LEADING TO NO ANNUNCIATION AT THE SECONDARY LOCATION (NICU) AND THEREFORE A 5-MINUTE DELAY IN THE RESPONSE TEAM GETTING TO THE BABY POST-DELIVERY; HOWEVER, THERE WAS CONFIRMATION OF NO INJURY FROM THE EVENT. IF THE SYSTEM ISSUE OF A GRS10 BEING OFFLINE (LOST UNIT SERVER) LEADING TO NO ANNUNCIATION TO A SECONDARY LOCATION FOR A ¿CODE PINK¿ WERE TO RECUR IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. AS THE ¿CODE PINK¿ FOR THIS CUSTOMER CONSTITUTES AN OB EMERGENCY CALL FOR NICU TO BE PRESENT AT BIRTH FOR RESUSCITATION EFFORTS OF A FETUS, NEWLY BORN INFANT OR NEONATE AT RISK OR IN CARDIORESPIRATORY ARREST. HILLROM IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ¿CODE PINK¿ BUTTON WAS PUSHED ON THE L&D UNIT, THE ALARM SOUNDED ON L&D (PRIMARY LOCATION) AND NBN (SECONDARY LOCATION) HOWEVER DID NOT SOUND IN THE NICU (SECONDARY LOCATION). THE NICU TEAM GOT TO THE BABY 5 MINUTES POST-DELIVERY AND THERE WAS NO INJURY FROM THE EVENT. IT IS NOTED THE CODE PINK WAS SET FOR THE CUSTOMER TO SIGNIFY AN ¿ACTIVATION OF THE RESPONSE TEAM FOR A FETUS, NEWLY BORN INFANT, OR NEONATE AT RISK FOR OR IN CARDIORESPIRATORY ARREST.¿ THE CODE ANNUNCIATED AT THE PRIMARY LOCATION; HOWEVER, DID NOT ANNUNCIATE AT THE SECONDARY LOCATION LEADING TO A DELAY IN SECONDARY TEAM AWARENESS THAT THERE WAS A DELIVERY NEEDING IMMEDIATE ATTENTION. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044797 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 4.0 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown