MAUDE Adverse Event Report: CERNER CORPORATION SURGICAL MANAGEMENT; SOFTWARE

Model Number 2018.01.02 - 2018.01.09

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification (flash19-0547-p) on august 30, 2019 to all potentially impacted client sites.The software notification includes a description of the issue and an explanation that more information will be provided when the investigation is complete.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 surgical 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 millennium surgical management®.The issue involves cerner millennium surgical management® and affects users that utilize this application to complete perioperative documentation.In cerner millennium powerchart® or surgical powerchart®, the system unexpectedly closes the patient chart in perioperative documentation when the user navigates away from a segment or clicks next in a segment after entering data.The system then returns the user to case selection, perioperative tracking, or another application based on the application selected before opening perioperative documentation.Any data that was added to the most recent segment is not saved when the chart unexpectedly closes.Patient care can be delayed because additional effort is required to determine which data was not saved and then document the data again.Patient care may also be affected if providers make care decisions based on incomplete data in a patient's chart.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification (flash19-0547-0) on october 16, 2019 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 surgical 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 millennium surgical management®.The issue involves cerner millennium surgical management® and affects users that utilize this application to complete perioperative documentation.In cerner millennium powerchart® or surgical powerchart®, the system unexpectedly closes the patient chart in perioperative documentation when the user navigates away from a segment or clicks next in a segment after entering data.The system then returns the user to case selection, perioperative tracking, or another application based on the application selected before opening perioperative documentation.Any data that was added to the most recent segment is not saved when the chart unexpectedly closes.Patient care can be delayed because additional effort is required to determine which data was not saved and then document the data again.Patient care may also be affected if providers make care decisions based on incomplete data in a patient's chart.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: SURGICAL MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 8955831
• MDR Text Key: 214800151
• Report Number: 1931259-2019-00006
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018.01.02 - 2018.01.09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1