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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
ADVANCED BRAIN MONITORING INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-SIGNAL GROUP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOSERENITY
  SUBSTANTIALLY EQUIVALENT 2
BIOSERENITY SAS
  SUBSTANTIALLY EQUIVALENT 2
BLACKROCK NEUROMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRAINMASTER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CUMULUS NEUROSCIENCE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELECTRICAL GEODESICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVOKE NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDISYNC INC.
  SUBSTANTIALLY EQUIVALENT 1
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
  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
MITSAR CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MOBILEMEDTEK
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
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 3
NIHON KOHDEN AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEER MEDICAL PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SPARK NEURO INC.
  SUBSTANTIALLY EQUIVALENT 1
STELLATE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
WAVI CO.
  SUBSTANTIALLY EQUIVALENT 1
ZETO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7 7
2015 13 13
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 25 25
Mechanical Problem 17 17
Sparking 16 16
Detachment of Device or Device Component 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Overheating of Device 11 11
Temperature Problem 10 10
Use of Device Problem 10 10
Melted 9 9
Smoking 8 8
Break 7 7
Excessive Heating 7 7
Loss of Data 6 6
Device Sensing Problem 6 6
Unintended Movement 5 5
Device Fell 5 5
Fire 5 5
Device Inoperable 4 4
Device Operates Differently Than Expected 4 4
Material Integrity Problem 4 4
Communication or Transmission Problem 4 4
Device Tipped Over 4 4
Power Problem 4 4
Patient-Device Incompatibility 3 3
Battery Problem 3 3
Output Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Stops Intermittently 3 3
Electro-Static Discharge 3 3
Electrical /Electronic Property Problem 3 3
Thermal Decomposition of Device 3 3
Crack 3 3
No Display/Image 3 3
Display or Visual Feedback Problem 2 2
Component Falling 2 2
Loose or Intermittent Connection 2 2
Unintended Collision 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Markings/Labelling 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
Connection Problem 2 2
Computer Operating System Problem 1 1
Device Dislodged or Dislocated 1 1
Electronic Property Issue 1 1
Improper Device Output 1 1
Inadequate User Interface 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Vibration 1 1
Device Handling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Problem 1 1
Complete Loss of Power 1 1
Failure to Sense 1 1
Material Separation 1 1
Unable to Obtain Readings 1 1
Material Puncture/Hole 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Device Damaged Prior to Use 1 1
Intermittent Shock/Stimulation 1 1
Solder Joint Fracture 1 1
False Reading From Device Non-Compliance 1 1
Failure To Run On AC/DC 1 1
Signal Artifact/Noise 1 1
Electromagnetic Interference 1 1
Degraded 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 77 77
No Clinical Signs, Symptoms or Conditions 63 63
No Consequences Or Impact To Patient 22 22
Blister 5 5
Pain 4 4
Insufficient Information 3 3
No Patient Involvement 3 3
Not Applicable 3 3
No Information 3 3
Electric Shock 2 2
Lead(s), Burn(s) From 2 2
Bruise/Contusion 2 2
Burn(s) 2 2
Injury 2 2
Numbness 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Death 1 1
Edema 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Nerve Damage 1 1
Respiratory Distress 1 1
Seizures 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
Pressure Sores 1 1
No Code Available 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion II Apr-07-2010
2 LIFELINES NEURO COMPANY II Dec-20-2019
3 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jul-28-2018
4 Natus Neurology DBA Excel Tech., Ltd. (XLTEK) II Jan-04-2016
5 Natus Neurology Inc II Oct-13-2015
6 Nihon Kohden America Inc II Jan-14-2021
7 Stellate Systems II Apr-22-2013
8 Stellate Systems II Jan-11-2012
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