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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device index-generating electroencephalograph software
Definition Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Product CodeOLW
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CORTICAL DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEUROWAVE SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 15 15
2021 15 15
2022 27 27
2023 18 18
2024 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 33 33
High Readings 24 24
Temperature Problem 24 24
Low Readings 11 11
Increase in Pressure 10 10
Image Display Error/Artifact 10 10
Device Damaged Prior to Use 9 9
Erratic or Intermittent Display 5 5
Appropriate Term/Code Not Available 5 5
Material Split, Cut or Torn 4 4
Failure to Power Up 4 4
Computer Software Problem 3 3
Device Alarm System 3 3
Noise, Audible 3 3
Use of Device Problem 3 3
Connection Problem 2 2
Failure to Analyze Signal 2 2
Patient Device Interaction Problem 2 2
Protective Measures Problem 1 1
Fitting Problem 1 1
Unable to Obtain Readings 1 1
No Audible Prompt/Feedback 1 1
Overheating of Device 1 1
Insufficient Information 1 1
Failure to Run on Battery 1 1
High Test Results 1 1
Smoking 1 1
No Apparent Adverse Event 1 1
Defective Component 1 1
Communication or Transmission Problem 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
Insufficient Information 44 44
No Consequences Or Impact To Patient 7 7
No Patient Involvement 4 4
Injury 3 3
Oversedation 2 2
Pressure Sores 1 1
Awareness during Anaesthesia 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Death 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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