BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL INSTALLATION

    MDR report key: 16021161 · Received December 21, 2022

    Report

    Report Number
    2027454-2022-00027
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 21, 2022
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761985209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM NURSE CALL SYSTEM PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATIONS VIA DESIGNATED COMMUNICATION DEVICES (MAIN CONSOLE, ANCILLARY STAFF CONSOLE, HALLWAY DOME LIGHTS, MOBILE PHONES). LOCATING IS AN ADVANCED FEATURE OF THE NURSE CALL SYSTEM. WHEN REAL-TIME STAFF LOCATING BADGES ARE USED IN CONJUNCTION WITH THE NURSE CALL SYSTEM, IT ALLOWS STAFF TO HAVE THE ABILITY TO QUICKLY LOCATE AND COMMUNICATE WITH A FELLOW STAFF MEMBER. ADDITIONALLY, LOCATING BADGES EQUIPPED WITH A DURESS BUTTON, ALLOW A STAFF MEMBER TO INITIATE A DURESS (URGENT) CALL/ALERT FOR ASSISTANCE IN THE EVENT THE CAREGIVER IS NOT IN CLOSE PROXIMITY TO A NURSE CALL SYSTEM STATION/BUTTON. A REVIEW OF THE NURSE CALL LOG FILES SHOWED THAT A DURESS CALL WAS PLACED WHILE THE CAREGIVER¿S LOCATING BADGE WAS TRANSITIONING BETWEEN LOCATING MONITORS, AND THE CALL LOCATION WAS IDENTIFIED AS THE PREVIOUS PATIENT ROOM THE CAREGIVER WAS LOCATED IN. ADDITIONALLY, THE LOCATING MONITOR IN THE ROOM ASSOCIATED WITH THE EVENT DID NOT RECOGNIZE THE CAREGIVER¿S LOCATING BADGE AS BEING PRESENT UNTIL FORTY-FIVE SECONDS AFTER THE CAREGIVER ENTERED THE ROOM. MONITORS SEND INFRARED SIGNALS TO THE LOCATED BADGES THAT ENABLE BADGES TO ACCURATELY BROADCAST THEIR LOCATIONS. A LOCATING BADGE TYPICALLY TRANSMITS ITS LOCATION TO THE LOCATING MONITOR EVERY FOUR TO SIX SECONDS. MONITORS CAN BE POWERED BY LITHIUM D-CELL BATTERIES, OR, OPTIONALLY, BY A POWER ADAPTER. TROUBLESHOOTING DETERMINED THAT THE BED EXIT FUNCTION WORKED AS INTENDED AND THE ISSUE WAS DUE TO A NON FUNCTIONAL MONITOR. THE ASSOCIATED MONITOR WAS REPLACED, WHICH RESOLVED THE ISSUE. THE CUSTOMER CONFIRMED THERE WAS NO INJURY AS A RESULT OF THIS EVENT. IF THE EVENT OF A DURESS CALL DISPLAYING AT AN INCORRECT LOCATION WERE TO RECUR IT IS LIKELY TO RESULT IN SERIOUS INJURY OR DEATH, AS THE DURESS ALERT IS COMMONLY USED IN THE EVENT OF AN EMERGENCY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A STAFF DURESS CALL ALERTED SHOWING THE INCORRECT ROOM LOCATION. THE CUSTOMER ALSO REPORTED THAT THERE WAS A PATIENT FALL ASSOCIATED WITH THIS EVENT, HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO INJURY FROM THE FALL. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463458 NURSE CALL INSTALLATION SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 3.9 00887761985209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown