MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE

Model Number MPAGES 7.4 THROUGH MPAGES 8.0

Device Problem Computer Software Problem (1112)

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

Event Date 02/24/2022

Event Type  malfunction  

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 mpages®, 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 mpages ® worklist column.The issue involves cerner millennium mpages and affects users that utilize the primary contact column on an mpages worklist.The worklist can be used to assist clinicians in organizing and prioritizing their work by providing key information about a population of patients.The issue occurs when users update a primary contact in the primary contact column using the assign to provider, assign team, or medical service option.This will cause the primary contact assignment to be removed after users select the current primary contact.Patient care may be delayed if the primary contact, service, or team is not displayed as expected on a patient chart or a worklist used for physician rounding.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on march 23,2022 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.

Manufacturer Narrative

Cerner distributed a flash notification on july 14, 2022 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 distributed a flash notification on march 23,2022 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 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 mpages®, 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 mpages ® worklist column.The issue involves cerner millennium mpages and affects users that utilize the primary contact column on an mpages worklist.The worklist can be used to assist clinicians in organizing and prioritizing their work by providing key information about a population of patients.The issue occurs when users update a primary contact in the primary contact column using the assign to provider, assign team, or medical service option.This will cause the primary contact assignment to be removed after users select the current primary contact.Patient care may be delayed if the primary contact, service, or team is not displayed as expected on a patient chart or a worklist used for physician rounding.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MPAGES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 13893602
• MDR Text Key: 297813316
• Report Number: 1931259-2022-00004
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 7.4 THROUGH MPAGES 8.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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