BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 18378215 · Received December 21, 2023

    Report

    Report Number
    2027454-2023-00099
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVICARE NURSE CALL (NNC) SYSTEM IS A COMPREHENSIVE COMMUNICATION AND INFORMATION MANAGEMENT SYSTEM THAT HELPS CAREGIVERS PROVIDE THE BEST POSSIBLE CARE TO PATIENTS IN THE MOST EFFICIENT MANNER. THE SYSTEM FACILITATES COMMUNICATION WITHIN A NURSING UNIT. CAREGIVERS HAVE THE ABILITY TO QUICKLY LOCATE AND COMMUNICATE WITH A FELLOW STAFF MEMBER, AND PATIENTS CAN EASILY COMMUNICATE WITH CAREGIVERS, THE NURSING STATION, OR DIRECTLY TO THEIR PRIMARY CAREGIVER. TROUBLESHOOTING ACTIVITIES PERFORMED BY BAXTER FOUND ROOM 2808 WAS NOT CONFIGURED TO ROUTE TO THE PBX AS EXPECTED BY THE CUSTOMER. CODE BLUE CALLS FROM TOWERS 4 AND 6 WERE NOT CONFIGURED TO ROUTE TO THE PBX; HOWEVER, OUT OF CAUTION, THE BAXTER TECHNICIAN CHANGED THE CONFIGURATION IN THE NURSE CALL SYSTEM SO CODE BLUE CALLS FROM ROOMS IN THESE TOWERS ROUTED TO THE PBX OPERATOR. IN THIS EVENT, A CODE BLUE CALL DID NOT ROUTE TO THE PBX OPERATOR AS EXPECTED BY THE CUSTOMER; HOWEVER, THE CODE CALL DID PROPERLY ANNUNCIATE AT THE PRIMARY CONSOLE AND THERE WAS NO DELAY IN TREATING THE PATIENT. THE PATIENT SUBSEQUENTLY DIED, BUT THE NURSING SUPERVISOR CONFIRMED THE DEATH WAS UNRELATED TO THE CALL NOT ROUTING TO THE PBX THROUGH THE NURSE CALL SYSTEM. THE PATIENT DEATH WAS UNLIKELY RELATED TO THE CODE BLUE CALL NOT BEING CONFIGURED TO ROUTE TO THE PBX AS EXPECTED. HOWEVER, IF A MISSED CODE BLUE CALL BY THE HOSPITAL PBX OPERATOR WERE TO RECUR, IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH AS A MANUAL OR AUTOMATED FACILITY-WIDE ANNOUNCEMENT OF THE EVENT AND A SUMMONS FOR ASSISTANCE TO THE CODE BLUE CALL IS COMMONLY PERFORMED BY A PBX STAFF MEMBER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCIDENT WITH THE NURSE CALL SYSTEM IN WHICH A CODE BLUE CALL FROM ROOM 2808 DID NOT ROUTE TO THE PBX OPERATOR STATION BUT DID PROPERLY ANNUNCIATE AT THE PRIMARY CONSOLE AND THERE WAS NO DELAY IN TREATMENT. PER THE NURSING SUPERVISOR, THE PATIENT WAS NOT EXPECTED TO MAKE IT THROUGH THE NIGHT AND SUBSEQUENTLY DIED; HOWEVER, THE PATIENT¿S DEATH WAS UNRELATED TO THE ISSUE WITH THE NURSE CALL SYSTEM. IT WAS ADDITIONALLY REPORTED THAT A CODE BLUE CALL TEST WAS PERFORMED BY THE CUSTOMER IN OTHER PATIENT ROOMS IN TOWERS 4 AND 6 AND THE CALLS DID NOT ROUTE TO THE PBX. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278814 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown