MAUDE Adverse Event Report: CERNER CORPORATION REGISTRATION MANAGEMENT; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problem Computer Software Problem (1112)

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

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification (flash20-0692-0) on (b)(6) 2020 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 registration management®, nor are these products currently actively regulated by the fda.The issue involves cerner millennium registration management and affects users that process change accommodation orders to modify a patient's location.In cerner millennium, when the user places a change accommodation order in powerchart to update a patient's medical service, the patient location information may be displayed incorrectly, and inconsistently in certain contexts.The correct location is displayed when the patient's encounter is in context, such as the encounter conversation and the demographics bar.However, an incorrect location may be displayed when the patient's encounter is not in context, such as in patient list and tracking list.Patient care could be adversely affected, as there could be confusion over the patient's location.This issue could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: REGISTRATION MANAGEMENT
• 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: 10720548
• MDR Text Key: 213252799
• Report Number: 1931259-2020-00010
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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