MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM MPAGES; SOFTWARE

Model Number MPAGES 5.4 THROUGH MPAGES 7.1

Device Problem Computer Software Problem (1112)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february 11, 2021 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 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 patient timeline vital signs timeline component in mpages.® the issue involves cerner millennium mpages and affects users that utilize the patient timeline vital signs timeline component to review documented patient temperatures over time.When the user charts a patient's temperature with a value less than or equal to 35 degrees celsius and not a whole number, the system calculates the axis values incorrectly, and the temperatures are aligned incorrectly on the axis.Patient care could be adversely affected, if clinical decisions are based on patient results that are displayed inaccurately.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on february 11, 2021 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 august 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 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 patient timeline - vital signs timeline component in mpages®.The issue involves cerner millennium mpages and affects users that utilize the patient timeline - vital signs timeline component to review documented patient temperatures over time.When the user charts a patient's temperature with a value less than or equal to 35 degrees celsius and not a whole number, the system calculates the axis values incorrectly, and the temperatures are aligned incorrectly on the axis.Patient care could be adversely affected, if clinical decisions are based on patient results that are displayed inaccurately.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MILLENNIUM MPAGES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• MDR Report Key: 11317887
• MDR Text Key: 251093059
• Report Number: 1931259-2021-00004
• 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,distri
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 5.4 THROUGH MPAGES 7.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1