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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 December 31, 2012

• FY 2011
• FY 2012
• FY 2013
• All

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	117
Nov 2010	N/A	130
Dec 2010	N/A	81
Jan 2011	N/A	121
Feb 2011	N/A	40
Mar 2011	N/A	57
Apr 2011	N/A	33
May 2011	N/A	45
Jun 2011	N/A	65
Jul 2011	N/A	44
Aug 2011	N/A	45
Sep 2011	N/A	56

FY 2011 Total: 834

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	117
Nov 2010	N/A	131
Dec 2010	N/A	83
Jan 2011	N/A	121
Feb 2011	N/A	40
Mar 2011	N/A	57
Apr 2011	N/A	34
May 2011	N/A	45
Jun 2011	N/A	65
Jul 2011	N/A	44
Aug 2011	N/A	48
Sep 2011	N/A	59

FY 2011 Total: 844