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 Code	GWQ
Regulation Number	882.1400
Device Class	2

Premarket Reviews
Manufacturer	Decision
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
ZETO, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Sparking	15	15
Smoking	11	11
Detachment of Device or Device Component	11	11
Overheating of Device	9	9
Melted	9	9
Use of Device Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Mechanical Problem	8	8
Temperature Problem	7	7
Excessive Heating	7	7
Break	6	6
Device Fell	5	5
Fire	5	5
Loss of Data	5	5
Unintended Movement	4	4
Electrical /Electronic Property Problem	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Crack	3	3
Material Integrity Problem	3	3
Electro-Static Discharge	3	3
Power Problem	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Loose or Intermittent Connection	2	2
No Apparent Adverse Event	2	2
Product Quality Problem	2	2
Output Problem	2	2
Thermal Decomposition of Device	2	2
Communication or Transmission Problem	2	2
Unintended Electrical Shock	2	2
Battery Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Patient-Device Incompatibility	2	2
Insufficient Information	2	2
Failure to Power Up	2	2
Device Dislodged or Dislocated	1	1
Complete Loss of Power	1	1
Electromagnetic Interference	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Intermittent Shock/Stimulation	1	1
Deformation Due to Compressive Stress	1	1
Device Displays Incorrect Message	1	1
Degraded	1	1
No Display/Image	1	1
Device Tipped Over	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Material Puncture/Hole	1	1
Unintended Collision	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	70
No Known Impact Or Consequence To Patient	26	26
No Consequences Or Impact To Patient	9	9
Blister	5	5
Electric Shock	2	2
Not Applicable	2	2
Insufficient Information	2	2
Lead(s), Burn(s) From	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
No Code Available	1	1
No Information	1	1
Memory Loss/Impairment	1	1
Burn, Thermal	1	1
Cognitive Changes	1	1
Burn(s)	1	1
Burning Sensation	1	1
No Patient Involvement	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Pain	1	1
Partial thickness (Second Degree) Burn	1	1
Bruise/Contusion	1	1