FDA Adverse Event Malfunction Summary report: N

CERNER MILLENIUM POWERCHART OFFICE & CORE

MDR report key: 1062230 · Received June 16, 2008

Report

Report Number: 1931259-2008-00006
Event Type: Malfunction
Date Received: June 16, 2008
Date of Event: May 20, 2008
Report Date: June 16, 2008
Manufacturer: CERNER CORPORATION
Product Code: LNX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CERNER HAS DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION JUNE 6, 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.

Description of Event or Problem · 1

THE ISSUE INVOLVES THE POWERCHART AND INET INTAKE AND OUTPUT SECOND GENERATION (I&O2G) FLOWSHEET FUNCTIONALITY AND AFFECTS SITES THAT USE INTAKE AND OUTPUT SECOND GENERATION (I&O2G). WHEN THE USER SETS THE FOCUS TO I&O2G FROM POWERCHART AND DOCUMENTS IV RESULTS DEFINED WITHIN A SPECIFIC DATE RANGE WITH HOURLY INTERVALS, INCOMPLETE INTAKE AND OUTPUT RESULTS AND TOTALS MAY BE DISPLAYED FOR THE INTAKE AND OUTPUT SECOND GENERATION (I&O2G). THERE IS NO INDICATION THAT SOME RESULTS OR TOTALS ARE NOT DISPLAYED. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PT EVENTS AS A RESULT OF THIS ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CERNER MILLENIUM POWERCHART OFFICE & CORE	SOFTWARE	LNX	CERNER CORPORATION	2007	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1