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U.S. Department of Health and Human Services

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Percent of “Code Blue” Medical Device Reports (MDRs) reviewed within 72 hours during the month

Dictionary: Code Blue is defined as high priority MDR reports based on criteria including but not limited to: pediatric deaths, multiple deaths and serious injuries, device explosions, and electrocutions. Timely review of code blue MDRs can minimize widespread failure of the device, thereby limiting the loss of life due to similar events as the one submitted.

Information is current as of September 30, 2013

Fiscal Year - 2011

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TimeTargetPercent
Oct 201090100
Nov 20109099
Dec 20109098
Jan 201190100
Feb 201190100
Mar 201190100
Apr 20119097
May 201190100
Jun 201190100
Jul 201190100
Aug 20119094
Sep 20119095

FY 2011 Overall: 99%

Number of “Code Blue” MDRs reviewed within 72 hours during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A117
Nov 2010N/A130
Dec 2010N/A81
Jan 2011N/A121
Feb 2011N/A40
Mar 2011N/A57
Apr 2011N/A33
May 2011N/A45
Jun 2011N/A65
Jul 2011N/A44
Aug 2011N/A45
Sep 2011N/A56

FY 2011 Total: 834

Total number of “Code Blue” MDRs reviewed during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A117
Nov 2010N/A131
Dec 2010N/A83
Jan 2011N/A121
Feb 2011N/A40
Mar 2011N/A57
Apr 2011N/A34
May 2011N/A45
Jun 2011N/A65
Jul 2011N/A44
Aug 2011N/A48
Sep 2011N/A59

FY 2011 Total: 844

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.