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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
Fiscal Year - 2013
| Time | Target | Percent |
|---|---|---|
| Oct 2012 | N/A | 96 |
| Nov 2012 | N/A | 97 |
| Dec 2012 | N/A | 94 |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 96%
Number of “Code Blue” MDRs reviewed within 72 hours during the month
Fiscal Year - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 50 |
| Nov 2012 | N/A | 74 |
| Dec 2012 | N/A | 67 |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 191
Total number of “Code Blue” MDRs reviewed during the month
Fiscal Year - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 52 |
| Nov 2012 | N/A | 76 |
| Dec 2012 | N/A | 71 |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 199
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.
