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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 - 2013

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TimeTargetPercent
Oct 20129096
Nov 20129097
Dec 20129094
Jan 20139091
Feb 20139097
Mar 20139085
Apr 20139093
May 20139089
Jun 20139094
Jul 20139098
Aug 20139098
Sep 20139084

FY 2013 Overall: 93%

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A50
Nov 2012N/A74
Dec 2012N/A67
Jan 2013N/A61
Feb 2013N/A71
Mar 2013N/A60
Apr 2013N/A50
May 2013N/A65
Jun 2013N/A97
Jul 2013N/A80
Aug 2013N/A92
Sep 2013N/A57

FY 2013 Total: 824

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A52
Nov 2012N/A76
Dec 2012N/A71
Jan 2013N/A67
Feb 2013N/A73
Mar 2013N/A71
Apr 2013N/A54
May 2013N/A73
Jun 2013N/A103
Jul 2013N/A82
Aug 2013N/A94
Sep 2013N/A68

FY 2013 Total: 884

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.