MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE

Model Number MPAGES 7.0 THROUGH MPAGES 7.2

Device Problem Computer Software Problem (1112)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on 02.July.2021 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 mpages®, 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 mpages.This issue affects users that utilize mpages to document or view consolidated, real-time view of patient information from various sources throughout the electronic health record (ehr).When a patient's name contains an apostrophe, an error is displayed and the user is unable to access that patient's mpages view.Patient care may be delayed if the clinician cannot view or document data for the patient through the desired mpages view.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MPAGES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkwa; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rock creek parkwa; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rock creek parkwa; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 12120421
• MDR Text Key: 259994502
• Report Number: 1931259-2021-00012
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 7.0 THROUGH MPAGES 7.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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