BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL INSTALLATION

    MDR report key: 15253736 · Received August 18, 2022

    Report

    Report Number
    2027454-2022-00007
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 23, 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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED CODE BLUE CALLS WERE NOT GOING THROUGH TO THE PBX ROOM ON THE GROUND FLOOR. THE PBX LOCATION IS AN OPTIONAL SECONDARY NOTIFICATION FOR CENTRALIZED ROUTING OF CODE BLUE CALLS. CALL ANNUNCIATION AT THE PRIMARY OR DEDICATED NURSE CALL CONSOLES IS NOT IMPACTED. NO PATIENT IMPACT OR SAFETY ISSUES REPORTED. 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. BASED ON A RETROSPECTIVE REVIEW AND LACK OF INFORMATION AROUND THE REASON FOR THE UNIT NOT ALERTING TO THE PBX, 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 CODE BLUE CALLS WERE NOT GOING THROUGH TO THE PBX ROOM ON THE GROUND FLOOR. THE PBX LOCATION IS AN OPTIONAL SECONDARY NOTIFICATION FOR CENTRALIZED ROUTING OF CODE BLUE CALLS. CALL ANNUNCIATION AT THE PRIMARY OR DEDICATED NURSE CALL CONSOLES IS NOT IMPACTED. NO PATIENT IMPACT OR SAFETY ISSUES REPORTED. 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. FURTHER TROUBLESHOOTING INDICATED THE PBX GRS10 HAD BECOME DE-SERIALIZED LOOSING CONNECTION TO THE SERVER. THE PBX LOCATION IS AN OPTIONAL SECONDARY NOTIFICATION FOR CENTRALIZED ROUTING OF CODE BLUE CALLS. CALL ANNUNCIATION AT THE PRIMARY OR DEDICATED NURSE CALL CONSOLES IS NOT IMPACTED BY THE DISCONNECTION OF THE SECONDARY PBX GRS10. THE END USER WOULD STILL RECEIVE CODE BLUE ALERTS AT THE PRIMARY NURSE CALL CONSOLE. IF THE PBX GRS10 WERE TO LOSE CONNECTION TO THE SERVER, THE PBX GRS10 WOULD PROVIDE AN AUDIBLE AND VISUAL ALERT OF THE LOST CONNECTION. IN ADDITION, THE PRIMARY GRS10 ON EACH UNIT MONITORED BY THE PBX WOULD ALSO PROVIDE A SYSTEM ALERT INDICATING THAT THE PBX GRS10 IS DOWN. THE PBX GRS10 WAS RECONFIGURED TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE CALLS WERE NOT GOING THROUGH TO THE PBX ROOM ON THE GROUND FLOOR. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE CALLS WERE NOT GOING THROUGH TO THE PBX ROOM ON THE GROUND FLOOR. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038418 NURSE CALL INSTALLATION SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY P2599NNCINSTALL 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown