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U.S. Department of Health and Human Services

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

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CERNER CORP. CERNER MILLENNIUM POWERCHART SOFTWARE Back to Search Results
Model Number 2005.02
Event Date 08/31/2007
Event Type  Malfunction  
Event Description

The issue involves the results to endorse (rte) inbox functionality in powerchart, powerchart office and firstnet and affects users that use the rte inbox to view radiology reports that have been created in radnet. Radiology results might fail to be displayed in the ordering provider's results to endorse folder in the inbox. Treatment or diagnosis decisions could be delayed if the clinician is relying on the display of a result in the inbox results to endorse folder to initiate patient follow-up. Note: the final results are posted to the flowsheet and are available on the patient's chart. Cerner received communication that a patient's follow-up care was delayed as a result of this issue.

 
Manufacturer Narrative

Cerner has distributed a priority review flash notification september 26, 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 has been developed and is available to address the issue for all sites that could be potentially impacted. Cerner corporation considers this issue resolved and no further narrative is required for follow-up.

 
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Brand NameCERNER MILLENNIUM POWERCHART
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 pkwy.
kansas city , MO 64117
(816) 201 -1368
Device Event Key908431
MDR Report Key920819
Event Key883013
Report Number1931259-2007-00005
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 09/27/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2005.02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/31/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/14/2005
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/27/2007 Patient Sequence Number: 1
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