BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER CAREAWARE IBUS

    MDR report key: 20852383 · Received December 5, 2024

    Report

    Report Number
    20852383
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    June 17, 2024
    Report Date
    September 22, 2024
    Manufacturer
    CERNER CORPORATION
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A YEARLY UPGRADE OF OUR CERNER SYSTEM, OUR DEVICES WERE TESTED FOR INTEGRATION BETWEEN CERNER AND HOSPITAL MONITORING EQUIPMENT. UNKNOWN TO OUR STAFF, CERNER COMPLETED AN UPGRADE TO ONE OF THE DRIVERS ON OUR CONNECTIVITY ENGINES (CE), DEVICES THAT BRIDGE THE CONNECTION FROM OUR GE EQUIPMENT TO CERNER'S IBUS SYSTEM. THE UPDATE TO THIS DRIVER CAUSED OUR PATIENT MONITORS IN OUR POST ANESTHESIA CARE UNIT (PACU) AND SURGERY TO LONGER MAINTAIN A CONNECTION TO THE ELECTRONIC MEDICAL RECORD (EMR) AFTER 24 HOURS, REQUIRING DAILY REBOOTS TO THESE CE DEVICES. CERNER WAS UNABLE TO IDENTIFY WHAT THE ISSUE WAS AND PUT THE SOLUTION ON THE HOSPITAL TO CORRECT ANY PROBLEMS WITH OUR EQUIPMENT EVEN THOUGH NO MODIFICATIONS WERE MADE ON OUR END. THE PROBLEM TOOK 6 WEEKS TO CORRECT. CERNER ADVISED US THE ISSUE WAS FOUND AT SEVERAL OTHER HOSPITALS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113588 CERNER CAREAWARE IBUS TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY DRG CERNER CORPORATION CAREAWAREIBUS5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose