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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM POWERCHART TASK LIST; SOFTWARE

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CERNER CORPORATION CERNER MILLENNIUM POWERCHART TASK LIST; SOFTWARE Back to Search Results
Model Number 2018.10.04 - 2018.11.03
Device Problem Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on june 3, 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.
 
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 powerchart® task list, 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 powerchart® task list.The issue affects providers that utilize the task list to manage workflow processes and support care management by accessing activities, viewing patient data, and document activities and findings.In cerner millennium, when the user views the task list summary, stat tasks are not displayed at the top of their sorted group when task list is opened to the default presorted list.Typically, stat tasks are sorted to allow pending stat tasks to be displayed above other tasks in a pending status by default.Currently, stat tasks are displayed at the bottom of their sorted group.Patient care could be adversely affected if providers cannot easily view the actions associated with performing a stat task, such as collecting a specimen or running a test, in a timely manner, potentially resulting in delayed care.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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Brand Name
CERNER MILLENNIUM POWERCHART TASK LIST
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
shelley looby
8779 hillcrest road
kansas city, MO 64138
8162011368
MDR Report Key14627766
MDR Text Key301370759
Report Number1931259-2022-00006
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2018.10.04 - 2018.11.03
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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