MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM POWER FORMS CLINICAL CONTENT; SOFTWARE

Model Number ADULT ACUTE NURSING APRIL 2020 - DECEMBER 2020

Device Problem Computer Software Problem (1112)

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

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification january 19, 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 dynamic documentation®, nor are these products currently actively regulated by the fda.The issue involves cerner millennium power forms clinical content and affects users that utilize the application for patient triage decisions.The smart template calculation is sending inaccurate information for patient triage decisions, based on incorrect sequential organ failure assessment (sofa) and modified sequential organ failure assessment (msofa) scores calculated in the sequential organ failure assessment (sofa) powerform.The spo2/fio2 ratio is currently calculated by dividing the lowest spo2 value from the last 24 hours by the lowest fio2 value from the last 24 hours, instead of calculating a spo2/fio2 ratio each time spo2 and fio2 are documented to determine the lowest ratio for the time period.This issue could lead to resulting in inaccurate information being used during triage.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MILLENNIUM POWER FORMS CLINICAL CONTENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rock creek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 11203188
• MDR Text Key: 278376820
• Report Number: 1931259-2021-00002
• 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: Notification
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ADULT ACUTE NURSING APRIL 2020 - DECEMBER 2020
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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