BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL

    MDR report key: 18125303 · Received November 13, 2023

    Report

    Report Number
    2027454-2023-00095
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 15, 2023
    Report Date
    November 13, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DURING TROUBLESHOOTING ACTIVITIES BY BAXTER, IT WAS FOUND THAT THE PBX CONSOLE WAS ONLY MONITORING TWO ROOMS IN THE UNIT. THE CUSTOMER RECALLED THE CVICU UNIT HAD BEEN UNDER CONSTRUCTION FOR TWO MONTHS THIS YEAR AND BELIEVED THERE WAS A MISCOMMUNICATION ON THE HOSPITAL'S PART WHEN THE ROOMS WENT BACK UP TO HAVE THE PBX RE-MONITOR THE OTHER ROOMS. THE BAXTER TECHNICIAN CONFIGURED THE ROOM TO BE MONITORED BY THE PBX CONSOLE AND REQUESTED THE CUSTOMER TEST THE ROOM TO CONFIRM FUNCTIONALITY. IN THIS EVENT, THERE WAS NO PATIENT INJURY, BUT A DELAY IN THE ARRIVAL OF EMERGENCY TEAM MEMBERS OCCURRED BECAUSE THE CODE BLUE CALL DID NOT ROUTE TO THE PBX STATION. A MISSED CODE BLUE CALL BY THE HOSPITAL PBX OPERATOR IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF IT WERE TO RECUR, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT RECORD WILL BE REASSESSED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCIDENT WITH THE NURSE CALL SYSTEM IN WHICH A CODE BLUE CALL FROM ROOM 2036 IN THE CVICU DID NOT ROUTE TO THE PBX STATION. THE CUSTOMER CONFIRMED THE DOME LIGHT OUTSIDE THE PATIENT¿S ROOM ILLUMINATED AND THE CODE BLUE CALL ROUTED TO THE MAIN CONSOLE AT THE NURSE¿S STATION IN THE UNIT. THERE WAS NO PATIENT INJURY REPORTED; HOWEVER, THERE WAS A 5¿10-MINUTE DELAY IN RESUSCITATION EFFORTS AND ARRIVAL OF EMERGENCY TEAM MEMBERS. FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DELAY IN RESUSCITATION EFFORTS WAS UNSUCCESSFUL. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990896 NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown