U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

 CDRH Event Problem Codes

CDRH Event Problem Codes
Submitting Event Problem Codes
Coding Concepts
Coding Tools / Resource Files
Case Studies
Requesting a New Code
Implementation Specifications
Subscribe to Email Updates on CDRH Event Problem Codes

Coding Tools/Resource Files

Use the following files to assist in downloading, viewing, selecting the appropriate CDRH Event Problem Codes.

The following 11 Device Problem Codes still exist as part of the code enhancements; HOWEVER, please note changes to the FDA code numbers. All code changes are reflected in all the Resource Files. These Device Problem Code numbers were changed to accommodate the introduction of Component Codes. For these codes only - the old FDA code numbers will be accepted until July 1, 2009, but not after that date. Please check back for updates.

Term

C-code

Old FDA Code

NEW FDA CODE

Failure to run on AC/DC

C63162

1001

3158

Accessory incompatible

C63036

1004

3136

Air leak

C63311

1008

3140

Delayed alarm

C63247

1011

3143

Device alarm system issue

C63033

1012

3144

False alarm

C63152

1013

3145

Defective Alarm

C63251

1014

3146

Low audible alarm

C63049

1016

3148

Not audible alarm

C63310

1019

3150

Alarm not visible

C63309

1022

3153

Failure to Adhere or Bond

C63032

1031

3157

Supplemental Sources

The FDA resource files listed above will always contain the most up-to-date version of the CDRH Event Problem Codes. The following links to NCI vocabulary are provided for those who wish to explore more detailed information about the terms – e.g. synonyms, NCI code information, etc.

Note: While in the transition period between existing and improved coding systems, please expect significant differences between codes stored in the NCI databases and those referenced in FDA CDRH files.

FDA Data Council – Shows all FDA Data Standards Resources including FDA Terminology hosted by NCI Enterprise Vocabulary Services. This includes the CDRH Event Problem Codes.

NCI Thesaurus - Scroll down the webpage and click on CONNECT button to enter the thesaurus. Enter 'FDA Center for Devices and Radiological Health Terminology' in the initial search box to see all CDRH Event Problem Codes. You may also enter an individual code.

NCI Metathesaurus – To see all CDRH Event Problem Codes, enter ‘FDA Center for Devices and Radiological Health Terminology’ in the initial Search box to see all CDRH codes. You may also enter a known code description. The metathesaurus is similar to the NCI Thesaurus except it also shows a mapping of the particular term to other terminologies including MedDRA, ICD-9 etc. Mappings to other terminologies are located in the ‘Sources section’ that appears as part of the coding entry. Also included on the page are: Synonyms, Definitions, Concepts more general, Concepts more specific and Concepts related to the selected term. Note that the metathesaurus contains many terminologies so it may be more difficult to use than the NCI Thesaurus.

Updated March 24, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH