TPLC - Total Product Life Cycle

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Device	full-montage standard electroencephalograph
Regulation Description	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	12	12
Smoking	10	10
Melted	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Temperature Problem	7	7
Excessive Heating	7	7
Detachment of Device or Device Component	7	7
Mechanical Problem	6	6
Overheating of Device	6	6
Use of Device Problem	6	6
Fire	5	5
Loss of Data	5	5
Device Fell	5	5
Break	4	4
Unintended Movement	4	4
Output Problem	3	3
Crack	3	3
Electrical /Electronic Property Problem	3	3
Electro-Static Discharge	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Loose or Intermittent Connection	2	2
Connection Problem	2	2
Appropriate Term/Code Not Available	2	2
Power Problem	2	2
No Apparent Adverse Event	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Product Quality Problem	2	2
Sharp Edges	2	2
Thermal Decomposition of Device	2	2
Failure to Power Up	2	2
Battery Problem	2	2
Material Integrity Problem	2	2
Patient-Device Incompatibility	2	2
Unintended Electrical Shock	2	2
Communication or Transmission Problem	2	2
Data Problem	1	1
Degraded	1	1
Positioning Problem	1	1
Computer Software Problem	1	1
Data Back-Up Problem	1	1
Device Dislodged or Dislocated	1	1
Failure to Transmit Record	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Electromagnetic Interference	1	1
Material Puncture/Hole	1	1
Complete Loss of Power	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Intermittent Shock/Stimulation	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	72	72
No Known Impact Or Consequence To Patient	18	18
Blister	5	5
No Consequences Or Impact To Patient	4	4
Electric Shock	2	2
Not Applicable	2	2
Insufficient Information	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Memory Loss/Impairment	1	1
Burn, Thermal	1	1
Cognitive Changes	1	1
Burning Sensation	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Pain	1	1
Partial thickness (Second Degree) Burn	1	1
Lead(s), Burn(s) From	1	1
Bruise/Contusion	1	1