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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

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CERNER CORPORATION CONNECT NURSING; SOFTWARE Back to Search Results
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a preliminary flash notification on june 4, 2021 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 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 cerner's millennium connect nursing®, 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 connect nursing®, connect nursing android.The issue involves cerner millennium connect nursing and affects users that utilize connect nursing android to administer medications at the bedside.In connect nursing android, when a logged-in user receives a server error message and then logs out without selecting an option for the error message, an incorrect patient medication list may be displayed when a user logs in again and receives another server error message.Patient care could be adversely affected if medication administration occurs for an incorrect patient if the incorrect patient medication list is displayed.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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 millennium connect nursing®, 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 connect nursing®,connect nursing android.The issue involves cerner millennium connect nursing and affects users that utilize connect nursing android to administer medications at the bedside.In connect nursing android, when a logged-in user receives a server error message and then logsout without selecting an option for the error message, an incorrect patient medication list may be displayed when a user logs in again and receives another server error message.Patient care could be adversely affected if medication administration occurs for an incorrect patient if the incorrect patient medication list is displayed.Cerner has not received communication on any adverse patient events as a result of this issue.
 
Manufacturer Narrative
Cerner distributed a preliminary flash notification on june 4, 2021 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 a flash notification on july 01, 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.The resolution section now indicates resolved release availability.Cerner corporation required a follow-up report as the software modification is available.
 
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Brand Name
CONNECT NURSING
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
2800 rock creek parkway
kansas city, MO 64117
MDR Report Key11983058
MDR Text Key255636952
Report Number1931259-2021-00010
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
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 Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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