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TPLC
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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 Code
GWQ
Regulation Number
882.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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