: Public Class
Created: 3/11/2008 3:25:17 PM
Modified: 2/23/2012 3:23:13 PM
Project:
Advanced:
DEFINITION:<br /></p><p>Information captured while conducting research on a product.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>An electrical problem in a device. <br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  defectTypeCode
Details:
Map:AE=ProductInvestigation.defectType
Map:CTRv1.0=PerformedProductInvestigationResult.defectTypeCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of device-related events that characterize the reported event/problem.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;malfunction#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  deviceMalfunctionCode
Details:
Map:AE=ProductInvestigation.deviceMalfunctionCode
Map:CTRv1.0=PerformedProductInvestigationResult.deviceMalfunctionCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Codes are FDA CDRH device codes.#lt;br /#gt;#lt;/p#gt;
Public CD
  evaluationConclusionCode
Details:
Map:AE=ProductInvestigation.evaluationConclusionCode
Map:CTRv1.0=PerformedProductInvestigationResult.evaluationConclusionCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Based on FDA CDRH Conclusion Codes. #lt;br /#gt;#lt;/p#gt;
Public ST
  conclusion
Details:
Map:AE=ProductInvestigation.conclusionsText
Map:CTRv1.0=PerformedProductInvestigationResult.conclusion
Map:ICSRr2=ProductDefectAssessment.text (in IndividualCaseSafetyReport)
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A text or otherwise formatted description of the final results drawn from the investigation. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Tag Value
Map:CTRv1.0 PerformedProductInvestigationResult
Details:
 
Object Type Connection Direction Notes
«Comment_Requested» PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedProductInvestigationResult always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedProductInvestigationResult. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):