MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE

Model Number MPAGES 6.12 THROUGH MPAGES 8.2

Device Problem Computer Software Problem (1112)

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

Event Date 05/04/2022

Event Type  malfunction  

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 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 mpages® or millennium staff assignment, 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 mpages® worklist while using millennium staff assignment.The issue affects users that utilize the mpages worklist to track patients assigned to care givers.In cerner millennium, when the primary contact is added to a patient encounter, any staff previously assigned through millennium staff assignment to that same encounter would be unassigned.Patient care could be adversely affected, if a care giver is no longer assigned to a patient causing a delay or gap in care until the next staff assignment is made.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), 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 distributed a flash notification on (b)(6), 2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification which was 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 mpages® or millennium staff assignment, 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 mpages® worklist while using millennium staff assignment.The issue affects users that utilize the mpages worklist to track patients assigned to care givers.In cerner millennium, when the primary contact is added to a patient encounter, any staff previously assigned through millennium staff assignment to that same encounter would be unassigned.Patient care could be adversely affected, if a care giver is no longer assigned to a patient causing a delay or gap in care until the next staff assignment is made.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: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138
• MDR Report Key: 15029203
• MDR Text Key: 304789698
• Report Number: 1931259-2022-00008
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 6.12 THROUGH MPAGES 8.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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
• Patient Outcome(s): Disability