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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION RADIOLOGY MANAGEMENT; SOFTWARE
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CERNER CORPORATION RADIOLOGY MANAGEMENT; SOFTWARE Back to Search Results
Model Number 2007.19 TO 2018.02
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on april 7, 2020 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.
 
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 radiology management, 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 radiology management.The issue involves cerner millennium radiology management and affects users that utilize exam management and online worklist to automate and streamline the operations of a radiology department.The issue occurs when isolation information is added to existing patient encounters using an isolation order.If the requisition is printed in exam management or online worklist, the isolation indicator is not displayed on the requisition.Patient care could be adversely affected as caregivers and other patients could be exposed to the condition causing the isolation if the isolation indicator is not displayed on the printed requisition.Cerner has not received communication on any adverse patient events as a result of this issue.
 
Manufacturer Narrative
Cerner distributed a flash notification on april 7, 2020 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 flash20-0230-1 on august 21, 2020 to all potentially impacted client sites.The software notification includes a description of the issue and notice that a software modification has been developed to address the issue for all sites that could potentially be 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 radiology management, 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 radiology management.The issue involves cerner millennium radiology management and affects users that utilize exam management and online worklist to automate and streamline the operations of a radiology department.The issue occurs when isolation information is added to existing patient encounters using an isolation order.If the requisition is printed in exam management or online worklist, the isolation indicator is not displayed on the requisition.Patient care and user safety could be adversely affected as caregivers and other patients could be exposed to the condition causing the isolation if the isolation indicator is not displayed on the printed requisition.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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Brand Name
RADIOLOGY MANAGEMENT
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
2800 rock creek parkway
kansas city, mo
MDR Report Key9950068
MDR Text Key214800139
Report Number1931259-2020-00006
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
PMA/PMN Number
N/A
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2007.19 TO 2018.02
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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