TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BIOTRICITY
	SUBSTANTIALLY EQUIVALENT	2
KESTRA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICALGORITHMICS S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPACELABS HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2

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
Adverse Event Without Identified Device or Use Problem	3	3
Data Problem	3	3
Insufficient Information	2	2
Therapeutic or Diagnostic Output Failure	2	2
Computer Operating System Problem	2	2
Device Sensing Problem	2	2
Display or Visual Feedback Problem	2	2
Fluid/Blood Leak	2	2
Disconnection	1	1
No Display/Image	1	1
Output Problem	1	1
Wireless Communication 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
Material Too Rigid or Stiff	1	1
Use of Device Problem	1	1
Date/Time-Related Software Problem	1	1
Product Quality Problem	1	1
Telemetry Discrepancy	1	1
Power Problem	1	1
Improper Chemical Reaction	1	1
Inappropriate or Unexpected Reset	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	9	9
No Clinical Signs, Symptoms or Conditions	8	8
Insufficient Information	6	6
No Information	4	4
Hypersensitivity/Allergic reaction	1	1
Skin Irritation	1	1
Skin Inflammation/ Irritation	1	1
Burn(s)	1	1
Burning Sensation	1	1