MAUDE Adverse Event Report: CERNER CORPORATION CAREAWARE MULTIMEDIA; SOFTWARE

Model Number 2007.19 - 2018.15

Device Problem Computer Software Problem (1112)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february 10, 2023 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 millennium careaware multimedia¿, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner millennium careaware multimedia¿ study management.The issue involves careaware multimedia¿ and affects users that utilize study management to merge studies in cerner millennium.In certain scenarios, studies from a previous patient or encounter may be included in the merge operation for a current patient.Patient care could be adversely affected if clinical decisions are made based on images from a different patient.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 10, 2023 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 distributed a flash notification on july 16, 2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification which was 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 millennium careaware multimedia¿, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner millennium careaware multimedia¿ study management.The issue involves careaware multimedia¿ and affects users that utilize study management to merge studies in cerner millennium.In certain scenarios, studies from a previous patient or encounter may be included in the merge operation for a current patient.Patient care could be adversely affected if clinical decisions are made based on images from a different patient.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CAREAWARE MULTIMEDIA
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 16372742
• MDR Text Key: 309515090
• Report Number: 1931259-2023-00005
• 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: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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: 2007.19 - 2018.15
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• 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