DVDEFIC

Table Description: Device Deficiency Log

1.0 Data Dictionary

ITM_NAME	DSCR_1.0
ADDLACT	Additional action taken
AEDTDEF	Deficiency resulted in AE
AESEQ	AE#
COMM	Comments
DEVDEF	Device Deficiency
DEVICESN	Serial Number of Device
DEVTYPA	Device Name
RMANUM	RMA Number
RPTDT	Date of report
RTSPONS	Device returned to sponsor
SEQNO	Sequence Number
STARTDT	Start Date
STARTEST	Start Date Estimation
STOPDT	Stop Date
STOPEST	Stop Date Estimation

1.0 Code Book

ITM_NAME	CODE	DECODE_1.0
ADDLACT	0	No
ADDLACT	1	Yes
AEDTDEF	0	No
AEDTDEF	1	Yes
DEVDEF	1	inadequacy of identity
DEVDEF	2	inadequacy of quality
DEVDEF	3	inadequacy of durability
DEVDEF	4	inadequacy of reliability
DEVDEF	5	inadequacy of safety
DEVDEF	6	inadequacy of performance
DEVDEF	7	other
DEVTYPA	1	Study Watch
DEVTYPA	2	Study Hub
RTSPONS	0	No
RTSPONS	1	Yes
STARTEST	ACT	Actual date
STARTEST	DAY	Day estimated
STARTEST	MD	Month and Day estimated
STOPEST	ACT	Actual date
STOPEST	DAY	Day estimated
STOPEST	MD	Month and Day estimated