TPLC - Total Product Life Cycle

show TPLC since

Device	electrocardiograph, ambulatory (without analysis)
Product Code	MWJ
Regulation Number	870.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOTRICITY
	SUBSTANTIALLY EQUIVALENT	2
BRAEMAR MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
CAMNTECH, LTD
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC MONITORING SOFTWARE
	SUBSTANTIALLY EQUIVALENT	1
ET MEDICAL DEVICES SPA
	SUBSTANTIALLY EQUIVALENT	1
EXELYS LLC
	SUBSTANTIALLY EQUIVALENT	1
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
	SUBSTANTIALLY EQUIVALENT	2
INTRICON DATRIX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KESTRA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICALGORITHMICS S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEMTEC CORP.
	SUBSTANTIALLY EQUIVALENT	1
MORTARA INSTRUMENT, INC
	SUBSTANTIALLY EQUIVALENT	1
NORAV MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
NORTH EAST MONITORING INC.
	SUBSTANTIALLY EQUIVALENT	1
PLATINUM TEAM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SCOTTCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SENSYDIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPACELABS HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
SUZUKEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	5	5
Overheating of Device	4	4
Temperature Problem	4	4
Data Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Fluid/Blood Leak	3	3
Insufficient Information	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device Sensing Problem	2	2
Device Operates Differently Than Expected	2	2
Computer Operating System Problem	2	2
Display or Visual Feedback Problem	2	2
Leak/Splash	1	1
Disconnection	1	1
Wireless Communication Problem	1	1
Smoking	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Problem with Software Installation	1	1
Patient Device Interaction Problem	1	1
Visual Prompts will not Clear	1	1
Telemetry Discrepancy	1	1
Product Quality Problem	1	1
Power Problem	1	1
Inappropriate or Unexpected Reset	1	1
Improper Chemical Reaction	1	1
Material Too Rigid or Stiff	1	1
Use of Device Problem	1	1
Date/Time-Related Software Problem	1	1
Break	1	1
No Display/Image	1	1
Fire	1	1
Output Problem	1	1
Melted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	13	13
No Clinical Signs, Symptoms or Conditions	8	8
Insufficient Information	6	6
No Information	5	5
Burn(s)	2	2
Hypersensitivity/Allergic reaction	1	1
Skin Irritation	1	1
Skin Inflammation/ Irritation	1	1
Burning Sensation	1	1