BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETALINK

    MDR report key: 11163635 · Received January 13, 2021

    Report

    Report Number
    1931259-2021-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    November 12, 2020
    Report Date
    March 22, 2021
    Manufacturer
    CERNER CORPORATION
    Product Code
    HGM
    UDI-DI
    00853023006227
    PMA / PMN Number
    K091251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CERNER DISTRIBUTED A FLASH NOTIFICATION ON JANUARY 11, 2021 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER DISTRIBUTED A FLASH NOTIFICATION FLASH21-0013-1 ON MARCH 17, 2021 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND NOTICE THAT A SOFTWARE MODIFICATION HAS BEEN DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD POTENTIALLY BE IMPACTED. CERNER CORPORATION CONSIDERS THIS ISSUE TO BE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 0

    THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S FETALINK®. THIS ISSUE INVOLVES CERNER'S FETALINK AND AFFECTS USERS THAT UTILIZE FETALINK AS A DIAGNOSTIC AID WHICH DISPLAYS THE GRAPHICAL IMAGES OF FETAL AND MATERNAL HEART RATE AND OTHER DATA THAT ARE GATHERED FROM THE MONITORING DEVICES ATTACHED TO THE PATIENT. IN CERNER MILLENNIUM, WHEN THE USER ADDS AN ANNOTATION FOR A FETAL MONITOR THAT IS DISPLAYED IN THE CENTRAL MONITOR PERSPECTIVE WHILE THE PERSPECTIVE IS REFRESHED, THE APPLICATION MAY FREEZE, AND NEW DEVICE DATA MAY NO LONGER BE DISPLAYED. WHEN THIS HAPPENS, ALL DEVICE DATA FOR THE MONITORED LOCATIONS IN THE CENTRAL MONITOR PERSPECTIVE ARE OUT OF DATE, AND NEW DEVICE DATA, INCLUDING ALERTS AND NOTIFICATIONS, ARE NOT DISPLAYED. PATIENT CARE COULD BE ADVERSELY AFFECTED, AS CLINICIANS MAY NOT HAVE ACCESS TO ACCURATE AND UP-TO-DATE MATERNAL AND FETAL MONITORING DATA. THIS INCLUDES FETAL WAVEFORMS, VITAL SIGN CONTAINERS, ALERTS, NOTIFICATIONS, MONITORS POWERED ON OR OFF, OR A CHANGE IN MONITOR ASSOCIATION. THIS COULD RESULT IN PATIENT CARE DELAY. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A FLASH NOTIFICATION ON JANUARY 11, 2021 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE MODIFICATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S FETALINK¿. THIS ISSUE INVOLVES CERNER'S FETALINK AND AFFECTS USERS THAT UTILIZE FETALINK AS A DIAGNOSTIC AID WHICH DISPLAYS THE GRAPHICAL IMAGES OF FETAL AND MATERNAL HEART RATE AND OTHER DATA THAT ARE GATHERED FROM THE MONITORING DEVICES ATTACHED TO THE PATIENT. IN CERNER MILLENNIUM, WHEN THE USER ADDS AN ANNOTATION FOR A FETAL MONITOR THAT IS DISPLAYED IN THE CENTRAL MONITOR PERSPECTIVE WHILE THE PERSPECTIVE IS REFRESHED, THE APPLICATION MAY FREEZE, AND NEW DEVICE DATA MAY NO LONGER BE DISPLAYED. WHEN THIS HAPPENS, ALL DEVICE DATA FOR THE MONITORED LOCATIONS IN THE CENTRAL MONITOR PERSPECTIVE ARE OUT OF DATE, AND NEW DEVICE DATA, INCLUDING ALERTS AND NOTIFICATIONS, ARE NOT DISPLAYED. PATIENT CARE COULD BE ADVERSELY AFFECTED, AS CLINICIANS MAY NOT HAVE ACCESS TO ACCURATE AND UP-TO-DATE MATERNAL AND FETAL MONITORING DATA. THIS INCLUDES FETAL WAVEFORMS, VITAL SIGN CONTAINERS, ALERTS, NOTIFICATIONS, MONITORS POWERED ON OR OFF, OR A CHANGE IN MONITOR ASSOCIATION. THIS COULD RESULT IN PATIENT CARE DELAY. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59655 FETALINK SOFTWARE HGM CERNER CORPORATION FETALINK 200.3.0 TO FETALINK 200.5.0 N/A 00853023006227

    Patients

    Seq Age Sex Outcome Treatment
    1