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

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	63	63
No Known Impact Or Consequence To Patient	26	26
No Consequences Or Impact To Patient	9	9
Blister	5	5
Insufficient Information	2	2
Electric Shock	2	2
Lead(s), Burn(s) From	2	2
Not Applicable	2	2
No Information	1	1
No Code Available	1	1
No Patient Involvement	1	1
Burn, Thermal	1	1
Cognitive Changes	1	1
Bruise/Contusion	1	1
Burn(s)	1	1
Laceration(s)	1	1
Memory Loss/Impairment	1	1
Nerve Damage	1	1
Pain	1	1
Burning Sensation	1	1
Tingling	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Partial thickness (Second Degree) Burn	1	1