MAUDE Adverse Event Report: CENER CORPORATION DYNAMIC DOCUMENTATION; SOFTWARE

Model Number 2015.01 THROUGH 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on november 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 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 dynamic documentation®, nor are these products currently actively regulated by the fda.The issue involves cerner millennium dynamic documentation and affects users that utilize the application for modifying another author's patient notes.In cerner millennium, when the user attempts to modify an in progress or unauthenticated note authored by another user, and then forwards the note to the original author for review, notes may fail to authenticate, or go unsaved without any notification.This issue also occurs when the user attempts to modify a note that they are not already associated with and removes the original author as a cosigner.Patient care could be adversely affected, because unsaved documentation may cause incomplete, or inaccurate care.This issue could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on november 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 revised flash notification march 26, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification has been released 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 dynamic documentation®, nor are these products currently actively regulated by the fda.The issue involves cerner millennium dynamic documentation and affects users that utilize the application for modifying another author's patient notes.In cerner millennium, when the user attempts to modify an in progress or unauthenticated note authored by another user and then forwards the note to the original author for review, notes may fail to authenticate, or go unsaved without any notification.This issue also occurs when the user attempts to modify a note that they are not already associated with and removes the original author as a cosigner.Patient care could be adversely affected, because unsaved documentation may cause incomplete or inaccurate care.This issue could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: DYNAMIC DOCUMENTATION
• Type of Device: SOFTWARE
• Manufacturer (Section D): CENER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 10816508
• MDR Text Key: 215596494
• Report Number: 1931259-2020-00011
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 THROUGH 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1