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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE
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CERNER CORPORATION MPAGES; SOFTWARE Back to Search Results
Model Number MPAGES 6.11 THROUGH MPAGES 7.1
Device Problem Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on 27.March.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 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¿.The issue involves cerner millennium mpages¿.This issue affects users that utilize mpages¿ worklist column to deliver care directly within the workflow view.An incorrect resuscitation icon may be displayed in the worklist resuscitation column when a resuscitation order type mapping is not complete in a responsive worklist mpages view.Patient care can be affected if resuscitation decisions are made based on an incorrect resuscitation icon.This issue could result in serious injury.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 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®.The issue involves cerner millennium mpages®.This issue affects users that utilize mpages® worklist column to deliver care directly within the workflow view.An incorrect resuscitation icon may be displayed in the worklist resuscitation column when a resuscitation order type mapping is not complete in a responsive worklist mpages view.Patient care can be affected if resuscitation decisions are made based on an incorrect resuscitation icon.This issue could result in serious injury.Cerner has not received communication on any adverse patient events as a result of this issue.
 
Manufacturer Narrative
Cerner distributed a flash notification on 27.March.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 08.September.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.
 
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Brand Name
MPAGES
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
8779 hillcrest road
kansas city MO 64117
MDR Report Key11603539
MDR Text Key257219346
Report Number1931259-2021-00007
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 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMPAGES 6.11 THROUGH MPAGES 7.1
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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