• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEUROWAVE SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 3 3
2019 6 6
2020 15 15
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 15 15
Appropriate Term/Code Not Available 5 5
Device Damaged Prior to Use 3 3
Image Display Error/Artifact 3 3
Failure to Power Up 3 3
Low Readings 3 3
Connection Problem 2 2
Material Split, Cut or Torn 2 2
Incorrect Measurement 2 2
Device Emits Odor 2 2
Erratic or Intermittent Display 2 2
Smoking 2 2
Use of Device Problem 2 2
Fitting Problem 1 1
High Readings 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Fire 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Computer Software Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 9 9
No Patient Involvement 5 5
Injury 3 3
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
Insufficient Information 1 1
Pressure Sores 1 1
Awareness during Anaesthesia 1 1
Cardiac Arrest 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Aug-30-2018
-
-