MAUDE Adverse Event Report: CERNER CORPORATION REGISTRATION MANAGEMENT, SCHEDULING MANAGEMENT; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problems Device Issue (2379); Application Program Problem (2880)

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

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification flash17-0482-0 on august 14, 2017 to all potentially impacted client sites.The software notification includes a description of the issue and notification that a software modification has been developed and is available to address the issue for all sites that could be potentially impacted.Cerner corporation considers the issue 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 registration management ® or scheduling 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 registration management and scheduling management.The issue occurs when patients are combined in the application after completing the scheduling workflow.Patient demographic data may be lost if an error occurs during the combination because the combination fails, and the registration data is lost; however, the combined-away patient is inactivated in the database as expected.Patient care could be adversely affected if treatment decisions are made based on incomplete patient data.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: REGISTRATION MANAGEMENT, SCHEDULING MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 6792664
• MDR Text Key: 82998727
• Report Number: 1931259-2017-00003
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/14/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1