Three new terms:

FDA	C54451	Medical Device Problem Codes FDA CDRH	C91396	3198	MEDICATION ERROR		Event in which the device software design results in errors of medication preparation or administration.	An error in medication preparation or administration attributed to software.	C62839	3014	PROGRAMMING ISSUE
FDA	C54451	Medical Device Problem Codes FDA CDRH	C91397	3196	DATA ISSUE		Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed.	Incorrect transfer, storage, display or updating of data.	C63305	2880	APPLICATION PROGRAM ISSUE
FDA	C54451	Medical Device Problem Codes FDA CDRH	C91398	3197	PATIENT DATA ISSUE		Event in which information is accessed by the healthcare provider and either the wrong patient of the wrong information is retrieved despite correct inquiry procedures.	The retrieval of incorrect data about a particular patient.	C91397	3196	DATA ISSUE


New FDA Parents, primarily to permit NCI to create hierarchy to post:

C49755	3049	DEVICE COMPONENT OR ACCESSORY				C19238		DIAGNOSTIC, THERAPEUTIC, OR RESEARCH EQUIPMENT
C19238		DIAGNOSTIC, THERAPEUTIC, OR RESEARCH EQUIPMENT		C62596		FDA CDRH TERMINOLOGY
C48655	3192	MISSING VALUE REASON			 		C62596		FDA CDRH TERMINOLOGY
C54027	2688	PATIENT PROBLEM/MEDICAL       				C62596		FDA CDRH TERMINOLOGY
C62996	2379	DEVICE ISSUE						C62596		FDA CDRH TERMINOLOGY


New or modified NCI definitions:

C19238 | C50412 | C50476 | C50492 | C50637 | C50837 | C16897 | C34620 | C34857 | C16897

New or modified FDA Definitions:
FDA	C54451	Medical Device Problem Codes FDA CDRH	C63117	1304	IMAGE DISPLAY ERROR		Event in which measurement functions produce erroneous results or the image display is corrupted.
FDA	C54451	Medical Device Problem Codes FDA CDRH	C63257	2903	LOSS OF DATA	DATA CORRUPTION	Event in which information is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten.
FDA	C54451	Medical Device Problem Codes FDA CDRH	C63108	2953	IMPROPER DEVICE OUTPUT		Issue associated with the inaccurate outcome of a measurement/values/data obtained from the device being different from displayed, printed, stored, or exported measurements/values/data.		C62941	3005	OUTPUT ISSUE

Modified FDA Parent:

FDA	C54451	Medical Device Problem Codes FDA CDRH	C63257	2903	LOSS OF DATA	DATA CORRUPTION	Event in which information is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten.		C91397	3196	DATA ISSUE


Modified FDA PT:

FDA	C54450	Patient Problem Codes FDA CDRH	C50745	2077	FRACTURE, SKULL		C3046	1870	FRACTURE(S)