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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CERNER POWERCHART LTC; SOFTWARE
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CERNER CORPORATION CERNER POWERCHART LTC; SOFTWARE Back to Search Results
Model Number N/A
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2013
Event Type  malfunction  
Manufacturer Narrative
Cerner notified all potentially impacted clients on october 4-6, 2017.This notification includes a description of the issue, alternative workflows and explanation that a software modification will be developed to address the issue for all sites that are potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.
 
Event Description
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as caretracker® or powerchart ltc® nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's caretracker and powerchart ltc.The issue occurs when fluid intake and output (i/o) observations are documented in caretracker and integrated into powerchart ltc.The i/o observations which are sent from caretracker into powerchart ltc are not being included in the i/o totals in powerchart ltc.Patient care could be adversely affected if treatment decisions are made based on incorrect i/o totals.
 
Event Description
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as caretracker® or powerchart ltc® nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's caretracker and powerchart ltc.The issue occurs when fluid intake and output (i/o) observations are documented in caretracker and integrated into powerchart ltc.The i/o observations which are sent from caretracker into powerchart ltc are not being included in the i/o totals in powerchart ltc.Patient care could be adversely affected if treatment decisions are made based on incorrect i/o totals.Cerner has not received communication of any adverse patient events as a result of this issue.
 
Manufacturer Narrative
Cerner notified all potentially impacted clients on october 4-6, 2017.This communication includes a description of the issue, alternative workflows and explanation that a software modification will be developed to address the issue for all sites that are potentially impacted.Cerner notified all potentially impacted clients on march 1, 2018.This notification explained that a software modification is available to address the issue for all sites that could potentially be impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
 
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Brand Name
CERNER POWERCHART LTC
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
2800 rockcreek parkway
kansas city MO 64117
MDR Report Key6959378
MDR Text Key90587459
Report Number1931259-2017-00005
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/16/2013
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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