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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATIONCERNER MILLENNIUM POWERCHART, OFFICESOFTWARE

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CERNER CORPORATION CERNER MILLENNIUM POWERCHART, OFFICE SOFTWARE   Back to Search Results
Model Number 2007.15
Event Date 06/13/2008
Event Type  Malfunction   Patient Outcome  Other
Event Description

Follow-up treatment delay. The issue involves the message center functionality in powerchart and powerchart office, and affects users that utilize the message center to forward radiology reports. When radiology results for review are endorsed and forwarded by the ordering provider using the ok and next buttons, the results do not forward and are not displayed in the recipient's message center. Patient care may be affected if clinicians utilize the message center to communicate patient follow-up activities. Note: the final results are posted and are available on the patient's chart. Cerner has received communication of two delays in patient follow-up activities as a result of this issue.

 
Manufacturer Narrative

Cerner has distributed a priority review flash notification in 2008 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 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. Add'l model# 2007. 16.

 
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Brand NameCERNER MILLENNIUM POWERCHART, OFFICE
Type of DeviceSOFTWARE
Manufacturer (Section F)
CERNER CORPORATION
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer (Section D)
CERNER CORPORATION
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer Contact
shelley looby
2800 rockcreek pkwy.
kansas city , MO 64117
(816) 201 -1368
Device Event Key1239938
MDR Report Key1075747
Event Key1033710
Report Number1931259-2008-00007
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 07/11/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2007.15
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/13/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2006
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

Patient TREATMENT DATA
Date Received: 07/11/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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