C54030Level 6

Device Evaluation Conclusion

**Semantic type:** Functional Concept

**Definition:** A conclusion of a device evaluation.

**Synonyms:** - EVALUATION CONCLUSION

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C139469Appropriate Investigation Conclusion Term/Code Not Available

C139470Cause Traced to Non-Device Related Factors

C139471Cause Not Established

C139472Cause Traced to Component Failure

C139473Cause Traced to Environment

C139474Cause Traced to Transport/Storage

C139475Falsified Device

C139476Design Change Validation Inadequate

C139477Design Inadequate for Purpose

C139478Human Factors Engineering - Device Difficult to Assemble

C139479Human Factors Engineering - Device Difficult to Operate

C139480Human Factors Engineering - Device Difficult to Reprocess

C139481Cause Traced to Missing or Inadequate Safety Measures

C139482Sabotage or Intentional Misuse

C139525Adverse Event Related to Commutability

C139526Adverse Event Related to Procedure

C187265Reasonably Foreseeable Misuse

C193386Malfunction Observed Without Conclusive Finding

C206571Unable to Exclude Device Problem

C206572Device Problem Excluded

C91867Cannot Complete Investigation Incomplete Device Returned Evaluation Conclusion

C91868Conclusion not Yet Available

C91869Cause Traced to Device Design

C91871Device Discarded by User Unable to Follow-up Evaluation Conclusion

C91872Adverse Event Related to Patient Anatomy and/or Condition

C91873Failure to Follow Instructions

C91874Cause Traced to User

C91875Device Inconclusive Investigation in Progress Evaluation Conclusion

C91876Device Incorrectly Prepared for Use or Modified Evaluation Conclusion

C91877Cause Traced to Infrastructure

C91878Known Inherent Risk of Device

C91879Cause Traced to Labeling

C91880Cause Traced to Maintenance

C91881Manufacturing Deficiency

C91882Device not Manufactured by Reporting Firm Evaluation Conclusion

C91883Device not Returned Evaluation Conclusion

C91884Device Operational Context Caused or Contributed to Event Evaluation Conclusion

C91885Cause Traced to Manufacturing

C91886Device Received in Condition Making Evaluation Impossible Evaluation Conclusion

C91887Device Received Unused in Original Package Evaluation Conclusion

C91888Device Repaired and Returned Evaluation Conclusion

C91889Cause Traced to Training

C91890No Failure Detected Device Operated within Specification Evaluation Conclusion

C91891No Failure Detected Device out of Specification Evaluation Conclusion

C91892Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use

C91893Reuse of Single Use Device

C91894No Problem Detected

C91895Unintended Use Error Caused or Contributed to Event

C92048End of Life Problem Identified

C92099Quality Control Deficiency

C92106Shelf Life/Expiration Date Exceeded

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