: Public Class
Created: 3/11/2008 3:25:17 PM
Modified: 8/26/2017 1:19:11 AM
Project:
Advanced:
DEFINITION:<br/>Information captured while conducting research on a product.<br/><br/>EXAMPLE(S):<br/>An electrical problem in a device. <br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  defectTypeCode
Details:
Map:AE=ProductInvestigation.defectType
Map:CTRv1.0=PerformedProductInvestigationResult.defectTypeCode
Notes: DEFINITION:<br/>A coded value specifying the kind of device-related events that characterize the reported event/problem.<br/><br/>EXAMPLE(S):<br/>malfunction<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  deviceMalfunctionCode
Details:
Map:AE=ProductInvestigation.deviceMalfunctionCode
Map:CTRv1.0=PerformedProductInvestigationResult.deviceMalfunctionCode
Notes: DEFINITION:<br/>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. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Codes are FDA CDRH device codes.<br/>
Public CD
  evaluationConclusionCode
Details:
Map:AE=ProductInvestigation.evaluationConclusionCode
Map:CTRv1.0=PerformedProductInvestigationResult.evaluationConclusionCode
Notes: DEFINITION:<br/>A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Based on FDA CDRH Conclusion Codes. <br/>
Public ST
  conclusion
Details:
Map:AE=ProductInvestigation.conclusionsText
Map:CTRv1.0=PerformedProductInvestigationResult.conclusion
Map:ICSRr2=ProductDefectAssessment.text (in IndividualCaseSafetyReport)
Notes: DEFINITION:<br/>A text or otherwise formatted description of the final results drawn from the investigation. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:CTRv1.0 PerformedProductInvestigationResult
Details:
 
Object Type Connection Direction Notes
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):