TPLC - Total Product Life Cycle

• Device: standard polysomnograph with electroencephalograph
• Definition: Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
• Product Code: OLV
• Regulation Number: 882.1400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CEREBRA MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONSOLIDATED RESEARCH OF RICHMOND, INC
	SUBSTANTIALLY EQUIVALENT	1
CONSOLIDATED RESEARCH OF RICHMOND, INC. DBA GENERAL SLEEP CO
	SUBSTANTIALLY EQUIVALENT	1
EB NEURO, S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
	SUBSTANTIALLY EQUIVALENT	2
NEUROTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
PERSONAL HEALTH INSTITUTE INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
SOMNOMEDICS GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	4	4
2018	3	3
2019	1	1
2021	3	3
2022	3	3
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	5	5
Computer Software Problem	2	2
Device Operates Differently Than Expected	2	2
Excessive Heating	2	2
Display or Visual Feedback Problem	1	1
Mechanical Problem	1	1
Self-Activation or Keying	1	1
Electro-Static Discharge	1	1
Sparking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9	9
No Patient Involvement	3	3
No Information	3	3
No Consequences Or Impact To Patient	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology Inc	II	Jul-28-2018