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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 2
BIOSERENITY SAS
  SUBSTANTIALLY EQUIVALENT 2
BRAINMASTER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CUMULUS NEUROSCIENCE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EVOKE NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDISYNC INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELINES LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDEIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEMORYMD INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMED S.P.A
  SUBSTANTIALLY EQUIVALENT 1
MOBILEMEDTEK
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 3
NATUS MEDICAL INCORPORATED DBA EXCEL_TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEUROELECTRICS BARCELONA S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
NEUROFIELD INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEER MEDICAL PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SPARK NEURO INC.
  SUBSTANTIALLY EQUIVALENT 1
WAVI CO.
  SUBSTANTIALLY EQUIVALENT 1
ZETO, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 28 28
2017 17 17
2018 15 15
2019 16 16
2020 30 30
2021 19 19
2022 16 16
2023 20 20
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 20 20
Mechanical Problem 17 17
Detachment of Device or Device Component 14 14
Sparking 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Overheating of Device 10 10
Melted 9 9
Use of Device Problem 9 9
Temperature Problem 9 9
Smoking 8 8
Break 7 7
Excessive Heating 7 7
Device Sensing Problem 6 6
Loss of Data 5 5
Device Fell 5 5
Unintended Movement 5 5
Material Integrity Problem 4 4
Power Problem 4 4
Device Operates Differently Than Expected 3 3
Patient-Device Incompatibility 3 3
Battery Problem 3 3
Device Tipped Over 3 3
Communication or Transmission Problem 3 3
Thermal Decomposition of Device 3 3
Crack 3 3
Electrical /Electronic Property Problem 3 3
Fire 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Inoperable 3 3
Electro-Static Discharge 3 3
Device Stops Intermittently 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Unintended Collision 2 2
No Display/Image 2 2
Component Falling 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Output Problem 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 2 2
Positioning Problem 1 1
Complete Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Dislodged or Dislocated 1 1
Electronic Property Issue 1 1
Inadequate User Interface 1 1
Computer Operating System Problem 1 1
Device Displays Incorrect Message 1 1
Deformation Due to Compressive Stress 1 1
Failure To Run On AC/DC 1 1
Signal Artifact/Noise 1 1
Display or Visual Feedback Problem 1 1
Electromagnetic Interference 1 1
Degraded 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Material Puncture/Hole 1 1
Failure to Sense 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Intermittent Shock/Stimulation 1 1
Solder Joint Fracture 1 1
Vibration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 64 64
No Clinical Signs, Symptoms or Conditions 63 63
No Consequences Or Impact To Patient 22 22
Blister 5 5
Pain 4 4
Not Applicable 3 3
No Information 2 2
Insufficient Information 2 2
Lead(s), Burn(s) From 2 2
Bruise/Contusion 2 2
Electric Shock 2 2
No Patient Involvement 2 2
Partial thickness (Second Degree) Burn 1 1
Pressure Sores 1 1
Numbness 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Burn(s) 1 1
Edema 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Nerve Damage 1 1
Respiratory Distress 1 1
Swelling 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Misdiagnosis 1 1
Tingling 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LIFELINES NEURO COMPANY II Dec-20-2019
2 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jul-28-2018
3 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jan-04-2016
4 Nihon Kohden America Inc II Jan-14-2021
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