BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL INSTALLATION

    MDR report key: 15253605 · Received August 18, 2022

    Report

    Report Number
    2027454-2022-00010
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    August 10, 2021
    Report Date
    March 30, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE CODE BLUE CALLS WERE NOT GOING THROUGH THE PBX SYSTEM AND WERE ALARMING LOCALLY ONLY. THE EVENT OCCURRED ON THE 3RD FLOOR ORTHO-SPINE UNIT ON (B)(6) 2021. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT. 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. INVESTIGATION OF THE REPORTED EVENT DETERMINED THE UNIT HAD BECOME UNMONITORED BY PBX AS A SECONDARY NOTIFICATION. THE SYSTEM WAS NOT CONFIGURED FOR THE UNIT TO ROUTE OR BE MONITORED FOR CODE CALLS TO THE PBX LOCATION. BASED ON A RETROSPECTIVE REVIEW AND LACK OF INFORMATION AROUND THE REASON FOR THE UNIT BECOMING UNMONITORED BY PBX (FACILITY¿S DECISION VS. PRODUCT/CONFIGURATION ISSUE), HILLROM IS REPORTING THE EVENT OF A MISSED SECONDARY CODE BLUE ALERT DUE TO BEING LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, IF IT WAS TO RECUR. THE COMPLAINT INVESTIGATION IS ONGOING. FOLLOW UP INFORMATION REGARDING THE INVESTIGATION AND ROOT CAUSE WILL BE PROVIDED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE CODE BLUE CALLS WERE NOT GOING THROUGH THE PBX SYSTEM AND WERE ALARMING LOCALLY ONLY. THE EVENT OCCURRED ON THE 3RD FLOOR ORTHO-SPINE UNIT ON (B)(6) 2021. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT. 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. INVESTIGATION OF THE REPORTED EVENT DETERMINED THE UNIT HAD BECOME UNMONITORED BY PBX AS A SECONDARY NOTIFICATION. THE SYSTEM WAS NOT CONFIGURED FOR THE UNIT TO ROUTE OR BE MONITORED FOR CODE CALLS TO THE PBX LOCATION. NO ADDITIONAL INFORMATION BECAME AVAILABLE. DUE TO THE AGE OF THE REPORTED EVENT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. BASED ON A RETROSPECTIVE REVIEW AND LACK OF INFORMATION AROUND THE REASON FOR THE UNIT BECOMING UNMONITORED BY PBX (FACILITY¿S DECISION VS. PRODUCT/CONFIGURATION ISSUE), HILLROM IS REPORTING THE EVENT OF A MISSED SECONDARY CODE BLUE ALERT DUE TO BEING LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, IF IT WAS TO RECUR. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CODE BLUE CALLS WERE NOT GOING THROUGH THE PBX SYSTEM AND WERE ALARMING LOCALLY ONLY. THE EVENT OCCURRED ON THE 3RD FLOOR ORTHO-SPINE UNIT ON (B)(6) 2021. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CODE BLUE CALLS WERE NOT GOING THROUGH THE PBX SYSTEM AND WERE ALARMING LOCALLY ONLY. THE EVENT OCCURRED ON THE 3RD FLOOR ORTHO-SPINE UNIT ON (B)(6) 2021. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244998 NURSE CALL INSTALLATION SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY P2599NNCINSTALL 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown