MAUDE Adverse Event Report: CERNER CORPORATION RADIOLOGY MANAGEMENT; SOFTWARE

Model Number 2010.01 THROUGH 2018.01

Device Problem Computer Software Problem (1112)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification january 25, 2023 to all potentially impacted client sites.The software notification includes a description of the issue, and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.

Event Description

The issue involves cerner radiology management system and affects users that have the preference to automatically accept vetting order enabled.When the user adds protocol comments for an exam (exam 1), and if the user then selects a second exam (exam 2) before saving the changes to exam 1, a message is displayed asking the user if they want to save the protocol changes.When the user selects yes, exam 2 is vetted instead of exam 1.Exam 1 is in a protocol status but not vetted, and exam 2 is vetted but not in a protocol status.As a result of not being vetted, exam 1 is not sent to the appropriate queue for scheduling.Patient care may be affected if there is a delay in scheduling of the radiology exam.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification january 25, 2023 to all potentially impacted client sites.The software notification includes a description of the issue, and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner distributed an updated flash on 4/26/2023 that includes the software modification that is available to all impacted clients.Cerner corporation considers this issue to be resolved and no further narrative is required.

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 radiology management, nor are these products currently actively regulated by the fda.The issue involves cerner radiology management system and affects users when they add protocol comments for an exam (exam 1), and if user than selects a second exam (exam 2) before saving the changes, a message is displayed asking user if they want to save the protocol changes.When user select yes, exam 2 is vetted instead of exam 1.Exam 1 is in a protocol status but not vetted, and exam 2 is vetted but not in a protocol status.As a result of not being vetted, ser is unable to schedule exam 1 for the patient.Patient care may be affected if there is a delay in scheduling of the radiology exam.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: RADIOLOGY MANAGEMENT
• 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: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162010605
• MDR Report Key: 16244008
• MDR Text Key: 308359376
• Report Number: 1931259-2023-00003
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010.01 THROUGH 2018.01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• 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