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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER MILLENNIUM POWERCHART/POWERORDERS

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CERNER MILLENNIUM POWERCHART/POWERORDERS Back to Search Results
Event Date 01/10/2007
Event Type  Malfunction  
Event Description

The issue involves the powerorders functionality, used within the powerchart and powerchart office systems. Certain workflows that involve viewing multiple pts in the powerorders and other tabs could cause a mismatch between the identifying info displayed in the demographics banner and the clinical info displayed in the order profile. It is possible for clinicians to place a new order or perform order actions on existing orders while the demographic-order info mismatch exists. A clinician intends to perform an order action for one pt (pt b), whose name is displayed in the demographics banner, while the order action will actually be applied to another pt (pt a), whose order info is displayed in the order profile. Mfr reporter has not been made aware of any adverse pt care events that resulted from this issue.

 
Manufacturer Narrative

Mfr has distributed a priority review flash notification february 8, 2007 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed and will be available to address the issue for all sites that could be potentially impacted. Mfr will provide an update to you when the software correction has been made available to all clients.

 
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Brand NameCERNER MILLENNIUM POWERCHART/POWERORDERS
Type of DevicePOWERCHART/POWERORDERS
Manufacturer Contact
shelley looby
2800 rockcreek parkway
kansas city , MO 64117
(816) 201 -1368
Device Event Key821990
MDR Report Key834678
Event Key797600
Report Number1931259-2007-00001
Device Sequence Number1
Product CodeLNX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 02/09/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/10/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/09/2007 Patient Sequence Number: 1
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