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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device full-montage standard electroencephalograph
Definition Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Product CodeGWQ
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSERENITY
  SUBSTANTIALLY EQUIVALENT 1
BIOSERENITY SAS
  SUBSTANTIALLY EQUIVALENT 2
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CUMULUS NEUROSCIENCE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDISYNC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROFIELD INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEER MEDICAL PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SPARK NEURO INC.
  SUBSTANTIALLY EQUIVALENT 1
WAVI CO.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 16 16
2020 30 30
2021 19 19
2022 16 16
2023 20 20
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 11 11
Sparking 9 9
Melted 9 9
Overheating of Device 9 9
Mechanical Problem 8 8
Smoking 8 8
Use of Device Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Temperature Problem 7 7
Excessive Heating 6 6
Break 6 6
Device Fell 5 5
Unintended Movement 4 4
Loss of Data 3 3
Material Integrity Problem 3 3
Electrical /Electronic Property Problem 3 3
Fire 3 3
Crack 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Electro-Static Discharge 3 3
Patient-Device Incompatibility 2 2
Battery Problem 2 2
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 2 2
Loose or Intermittent Connection 2 2
Thermal Decomposition of Device 2 2
Communication or Transmission Problem 2 2
Connection Problem 2 2
Output Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 1 1
Complete Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Positioning Problem 1 1
Power Problem 1 1
Degraded 1 1
No Display/Image 1 1
Electromagnetic Interference 1 1
Material Puncture/Hole 1 1
Unintended Collision 1 1
Deformation Due to Compressive Stress 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Inadequate User Interface 1 1
Device Damaged Prior to Use 1 1
Intermittent Shock/Stimulation 1 1
Solder Joint Fracture 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 26 26
No Consequences Or Impact To Patient 9 9
Blister 4 4
Insufficient Information 2 2
Electric Shock 2 2
Lead(s), Burn(s) From 2 2
Not Applicable 2 2
No Code Available 1 1
Burn(s) 1 1
No Patient Involvement 1 1
Burning Sensation 1 1
Laceration(s) 1 1
No Information 1 1
Tingling 1 1
Bruise/Contusion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Memory Loss/Impairment 1 1
Cognitive Changes 1 1
Partial thickness (Second Degree) Burn 1 1
Nerve Damage 1 1
Pain 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LIFELINES NEURO COMPANY II Dec-20-2019
2 Nihon Kohden America Inc II Jan-14-2021
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