MAUDE Adverse Event Report: CERNER CORPORATION REGISTRATION MANAGEMENT; SOFTWARE

Model Number 2015.01 TO 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on january 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.

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 registration management, 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 registration management.The issue involves cerner registration management and affects users that utilize the patient status order (pso) workflow to transfer or admit patients, or when using the self-declare relationship prompt in powerchart (powerchart.Exe) to establish the attending physician.In either workflow, the incorrect attending physician may be used for displaying providers' patient lists.The issue could result in a patient care delay if a patient is not displayed on the appropriate providers' patient list.Cerner has not received communication on any adverse patient events as a result of this issue.

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 registration management, 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 registration management.The issue involves cerner registration management and affects users that utilize the patient status order (pso) workflow to transfer or admit patients, or when using the self-declare relationship prompt in power chart (powerchart.Exe) to establish the attending physician.In either workflow, the incorrect attending physician may be used for displaying providers' patient lists.The issue could result in a patient care delay if a patient is not displayed on the appropriate providers' patient list.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a priority review flash notification flash19-0498-4 on april 3, 2020 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.

• Brand Name: REGISTRATION MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city, mo
• MDR Report Key: 9686714
• MDR Text Key: 204930493
• Report Number: 1931259-2020-00003
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 TO 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1