MAUDE Adverse Event Report: CERNER CORPORATION CERNER'S MILLENNIUM POWERCHART®, FIRSTNET®, SURGICAL POWERCHART® AND DISCERN®; SOFTWARE

Model Number 2007.19 THROUGH 2018.09

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february 24, 2020 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.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's clinical notes®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium clinical notes®.The issue involves cerner millennium clinical notes® and affects users that utilize the product to create and/or edit textual notes.In cerner millennium®, when the user opens a patient's chart in the clinical notes® tab and then open another patient's chart, the previous patient's documents may be displayed on the note list.However, the correct patient information is displayed in the demographics bar.Patient care could be adversely affected, as clinicians could review documents for a patient other than the one they intended if the documents from the previous patient's chart are displayed.This issue could impact the treatment and care of the patient.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2020 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 on (b)(6) 2021 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium powerchart®, firstnet®, surgical powerchart® and discern® output viewer, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium powerchart®, firstnet®, surgical powerchart® and discern® output viewer.This issue occurs when users have patient's chart open and then open a different patient's chart.The new patient's information is correctly displayed on the demographics bar; however, the system may continue to display the previous patient's information.Patient care could be adversely affected if a clinician reviews patient data for the incorrect patient and makes clinical decisions for a different patient based on that information.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER'S MILLENNIUM POWERCHART®, FIRSTNET®, SURGICAL POWERCHART® AND DISCERN®
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; cerner corporation; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 9765543
• MDR Text Key: 193336609
• Report Number: 1931259-2020-00004
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2007.19 THROUGH 2018.09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1