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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORP.CENER MILLENNIUM INET INTAKE AND OUTPUT 2GSOFTWARE

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CERNER CORP. CENER MILLENNIUM INET INTAKE AND OUTPUT 2G SOFTWARE   Back to Search Results
Event Date 08/02/2008
Event Type  Malfunction   Patient Outcome  Other
Event Description

The issue involves the results and reporting functionality in inet, and affects users that utilize or have installed intake and output second generation. The system fails to return intake and output results in intake and output second generation (pvino2. Dii). This can impact intake and output data that is displayed in cerner solutions and reports for powerchart local access (pcla), intake and output reports for medical record print (mrp), rounds reports, and the intake and output report produced in powerchart (powerchart. Exe). Other client-customized reports may be impacted. Cerner cannot determine which, if any, custom reports that display intake and output results will be affected, as the client custom report author may use many logic methods to determine the results to be displayed. Pt care could be adversely affected, as clinical decisions could be based on incomplete data. Cerner has not received communication of any adverse pt events as a result of this issue.

 
Manufacturer Narrative

Cerner has distributed a priority review flash notification january 23, 2009 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent malfunction. The software notification also includes a query for users to identify affected result and the manual steps to correct affected results. 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.

 
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Brand NameCENER MILLENNIUM INET INTAKE AND OUTPUT 2G
Type of DeviceSOFTWARE
Manufacturer (Section F)
CERNER CORP.
kansas city MO
Manufacturer (Section D)
CERNER CORP.
kansas city MO
Manufacturer Contact
shelley looby
2800 rockcreek pkwy.
kansas city , MO 64117
(816) 201 -1368
Device Event Key1486206
MDR Report Key1370640
Event Key1307351
Report Number1931259-2009-00002
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 01/28/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/02/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2006
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?
Type of Device Usage Unkown

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