MAUDE Adverse Event Report: CERNER CORPORATION HEALTHELIFE; SOFTWARE

Model Number HEALTHELIFE UI WEB RELEASES 2021.01.01 AND EARLIER

Device Problem Computer Software Problem (1112)

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

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february 19, 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 healthelife®, nor are these products currently actively regulated by the fda.The issue involves cerner millennium healthelife and affects users that utilize the e-visit or pre-visit questionnaires.In cerner millennium, when patients or authorized representatives complete an e-visit or pre-visit questionnaire, return to a previous page in the questionnaire and change the check box selections before submitting the questionnaire form, their responses may include the original selections instead of the updated selections.Patient care could be adversely affected, as providers reviewing questionnaire responses may not be aware of the questionnaire responses the patient intended to submit, potentially influencing care decisions or considerations.Providers may be required to review patient questionnaire responses more thoroughly with patients to ensure the accuracy of the information submitted in the questionnaire.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: HEALTHELIFE
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 11366191
• MDR Text Key: 280444867
• Report Number: 1931259-2021-00006
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/23/2021

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: No Information
• Device Model Number: HEALTHELIFE UI WEB RELEASES 2021.01.01 AND EARLIER
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1