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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORP.CERNER MILLENNIUM POWERCHART FLOWSHEETSOFTWARE

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CERNER CORP. CERNER MILLENNIUM POWERCHART FLOWSHEET SOFTWARE   Back to Search Results
Event Date 03/13/2006
Event Type  Malfunction  
Manufacturer Narrative

Cerner has distributed a priority review flash notification april,2006 to all potentially impacted client sites. The software notification includes a description of the issue and advises clients of an interim workflow adjustments 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. Cerner corp will provide an update to you when the software correction has been made available to all clients.

 
Event Description

The issue involves the direct charting flowsheet and icu flowsheet, used within the powerchart system. When the result details box is accessed for a negative result value in either the icu flowsheet or the direct charting flowsheet in powerchart, either by right-clicking a negative, unsigned result value and selecting chart details from the context menu, or by right-clicking a negative signed result value and selecting modify, the dialog box displays a blank result value. When the user clicks ok in the result details dialog box, the value is changed to zero in the result cell in the flowsheet.

 
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Brand NameCERNER MILLENNIUM POWERCHART FLOWSHEET
Type of DeviceSOFTWARE
Manufacturer (Section F)
CERNER CORP.
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer (Section D)
CERNER CORP.
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer Contact
shelley looby
2800 rockcreek parkway
kansas city , MO 64117
(816) 201 -1368
Device Event Key689205
MDR Report Key700117
Event Key666331
Report Number1931259-2006-00003
Device Sequence Number1
Product CodeMMH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 04/11/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2006
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
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1997
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 Invalid Data

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