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
Detachment of Device or Device Component	11	11
Smoking	11	11
Overheating of Device	9	9
Melted	9	9
Mechanical Problem	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Use of Device Problem	8	8
Temperature Problem	7	7
Excessive Heating	7	7
Break	6	6
Fire	5	5
Loss of Data	5	5
Device Fell	5	5
Unintended Movement	4	4
Electrical /Electronic Property Problem	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Electro-Static Discharge	3	3
Material Integrity Problem	3	3
Crack	3	3
Patient-Device Incompatibility	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Battery Problem	2	2
Failure to Power Up	2	2
Insufficient Information	2	2
Thermal Decomposition of Device	2	2
Product Quality Problem	2	2
No Apparent Adverse Event	2	2
Power Problem	2	2
Appropriate Term/Code Not Available	2	2
Unintended Electrical Shock	2	2
Connection Problem	2	2
Communication or Transmission Problem	2	2
Loose or Intermittent Connection	2	2
Output Problem	2	2
Positioning Problem	1	1
Degraded	1	1
Material Puncture/Hole	1	1
Data Problem	1	1
Solder Joint Fracture	1	1
Device Damaged Prior to Use	1	1
Device Markings/Labelling Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Device Dislodged or Dislocated	1	1
Electromagnetic Interference	1	1
Complete Loss of Power	1	1
No Display/Image	1	1
Intermittent Shock/Stimulation	1	1
Device Tipped Over	1	1
Deformation Due to Compressive Stress	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
Memory Loss/Impairment	1	1
No Information	1	1
Burn, Thermal	1	1
Cognitive Changes	1	1
Burn(s)	1	1
Burning Sensation	1	1
Nerve Damage	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Pain	1	1
Partial thickness (Second Degree) Burn	1	1
Bruise/Contusion	1	1