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	3
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
LIFELINES LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDEIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEMORYMD INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROMED S.P.A
	SUBSTANTIALLY EQUIVALENT	1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
	SUBSTANTIALLY EQUIVALENT	1
NATUS MEDICAL INCORPORATED DBA EXCEL_TECH LTD. (XLTEK)
	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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	17	17
Sparking	16	16
Detachment of Device or Device Component	14	14
Smoking	11	11
Overheating of Device	9	9
Melted	9	9
Use of Device Problem	9	9
Excessive Heating	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Temperature Problem	7	7
Break	6	6
Fire	5	5
Loss of Data	5	5
Unintended Movement	5	5
Device Fell	5	5
Material Integrity Problem	4	4
Device Tipped Over	3	3
Crack	3	3
Electrical /Electronic Property Problem	3	3
Electro-Static Discharge	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Battery Problem	3	3
Unintended Collision	2	2
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
Product Quality Problem	2	2
Misassembly by Users	2	2
Thermal Decomposition of Device	2	2
Failure to Power Up	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Insufficient Information	2	2
Patient-Device Incompatibility	2	2
Unintended Electrical Shock	2	2
Output Problem	2	2
Communication or Transmission Problem	2	2
Solder Joint Fracture	1	1
Data Problem	1	1
Unable to Obtain Readings	1	1
Material Separation	1	1
Degraded	1	1
Positioning Problem	1	1
Device Dislodged or Dislocated	1	1
Vibration	1	1
Failure to Sense	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Electromagnetic Interference	1	1
Material Puncture/Hole	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	38	38
No Consequences Or Impact To Patient	10	10
Blister	5	5
Not Applicable	3	3
Electric Shock	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
Misdiagnosis	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

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	Nihon Kohden America Inc	II	Jan-14-2021
4	SEER MEDICAL PTY LTD	II	Sep-13-2024
5	WAVi Co.	II	May-31-2024