Overview Top Package Entity

Business Data Model Data Model

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Entity Performed Product Investigation Result

Description

A performed observation result that records information captured while conducting research on a product. For example: An electrical problem in a device.

Attributes

Conclusion Txt

Defect Type

Device Malfunction Code

Evaluation Conclusion Code

Generalization

R_1608

Dependencies

NONE

Reverse Dependencies

Attribute Details

 Conclusion Txt

Description	A text or otherwise formatted description of the final results drawn from the investigation.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

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 Defect Type

Description	Specifies the kind of device-related events that characterize the reported event/problem. For example: malfunction
Data Type	Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

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 Device Malfunction Code

Description	A coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is associated with an adverse event. Codes are FDA CDRH device codes.
Data Type	Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

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 Evaluation Conclusion Code

Description	A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. Based on FDA CDRH Conclusion Codes.
Data Type	Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Generalization Details

 R_1608

Supertype	Performed Observation Result
Subtype	Performed Product Investigation Result
Transform As	TABLE

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Overview Top Package Entity

Business Data Model Data Model