TPLC - Total Product Life Cycle

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Device	index-generating electroencephalograph software
Definition	Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Product Code	OLW
Regulation Number	882.1400
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	46	46
Temperature Problem	26	26
High Readings	25	25
Low Readings	12	12
Image Display Error/Artifact	10	10
Increase in Pressure	10	10
Device Damaged Prior to Use	9	9
Device Alarm System	8	8
Appropriate Term/Code Not Available	5	5
Erratic or Intermittent Display	5	5
Material Split, Cut or Torn	4	4
Patient Device Interaction Problem	4	4
No Apparent Adverse Event	4	4
Failure to Power Up	4	4
Data Problem	3	3
Computer Software Problem	3	3
Use of Device Problem	3	3
Noise, Audible	3	3
Smoking	2	2
Defective Component	2	2
Connection Problem	2	2
Failure to Analyze Signal	2	2
Device Emits Odor	2	2
Failure to Run on Battery	2	2
Fitting Problem	1	1
Insufficient Information	1	1
No Audible Alarm	1	1
No Audible Prompt/Feedback	1	1
High Test Results	1	1
Protective Measures Problem	1	1
Image Orientation Incorrect	1	1
Overheating of Device	1	1
Display or Visual Feedback Problem	1	1
Unable to Obtain Readings	1	1
Communication or Transmission Problem	1	1
Fire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	66	66
Insufficient Information	57	57
No Consequences Or Impact To Patient	9	9
No Patient Involvement	5	5
No Known Impact Or Consequence To Patient	3	3
Injury	3	3
Skin Inflammation/ Irritation	2	2
Oversedation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
No Code Available	1	1
Cardiac Arrest	1	1
Awareness during Anaesthesia	1	1
Pressure Sores	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien LLC	II	Aug-30-2018