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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
Regulation Description Electroencephalograph.
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
2021 15 15
2022 27 27
2023 18 18
2024 93 96
2025 74 74
2026 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 128 128
Temperature Problem 46 46
High Readings 44 45
Device Damaged Prior to Use 23 23
Low Readings 23 23
Device Alarm System 21 21
Image Display Error/Artifact 19 19
Material Split, Cut or Torn 12 12
Increase in Pressure 10 10
Use of Device Problem 10 10
Communication or Transmission Problem 9 9
Failure to Power Up 8 8
Failure to Run on Battery 8 8
Patient Device Interaction Problem 6 8
No Apparent Adverse Event 4 4
Display or Visual Feedback Problem 4 4
Insufficient Heating 4 4
Unable to Obtain Readings 4 4
Data Problem 3 3
Erratic or Intermittent Display 3 3
Defective Component 3 3
Computer Software Problem 3 3
Failure to Analyze Signal 3 3
Naturally Worn 2 2
Noise, Audible 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Component Missing 1 1
Incomplete or Inadequate Connection 1 1
High impedance 1 1
No Audible Prompt/Feedback 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Protective Measures Problem 1 1
Connection Problem 1 1
Overheating of Device 1 1
High Test Results 1 1
Fitting Problem 1 1
Contamination /Decontamination Problem 1 1
Defective Alarm 1 1
Insufficient Device Problem Information 1 1
Image Orientation Incorrect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 173 173
Insufficient Information 98 99
Awareness during Anaesthesia 6 6
Oversedation 6 6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Pressure Sore/Ulcer 2 2
Skin Inflammation/ Irritation 2 4
Cardiac Arrest 1 1
Increased Level of Consciousness 1 1
Rash 1 1
Bruise/Contusion 1 1
Low Blood Pressure/ Hypotension 1 1

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