MAUDE Adverse Event Report: CERNER CORPORATION INTERACTIVE VIEW; SOFTWARE

Device Problem Computer Software Problem (1112)

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

Event Date 06/27/2022

Event Type  malfunction  

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 interactive view 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 interactive view.The device date and time are not stored in interactive view when results are retrieved from bedside medical device interfaces (bmdi).Currently, when bmdi results are retrieved, interactive view uses the start date and time of the time column as the clinical date and time for the device instead of the device date and time.Patient care may be affected if clinical decisions are made based on bmdi results that are charted with an interactive view date and time column that is different from the actual date and time on the device that captured the patient observation cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification (b)(6) 2022 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.

• Brand Name: INTERACTIVE VIEW
• 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: 16875837
• MDR Text Key: 314639889
• Report Number: 1931259-2023-00009
• 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: Notification
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2022
• Date Device Manufactured: 01/01/2005
• 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