TPLC - Total Product Life Cycle

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Device	index-generating electroencephalograph software
Regulation Description	Electroencephalograph.
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	85	85
Temperature Problem	36	36
High Readings	33	33
Device Damaged Prior to Use	19	19
Low Readings	17	17
Image Display Error/Artifact	13	13
Device Alarm System	10	10
Increase in Pressure	10	10
Material Split, Cut or Torn	9	9
Patient Device Interaction Problem	6	6
Use of Device Problem	5	5
Erratic or Intermittent Display	5	5
Appropriate Term/Code Not Available	5	5
Failure to Power Up	4	4
No Apparent Adverse Event	4	4
Defective Component	3	3
Unable to Obtain Readings	3	3
Data Problem	3	3
Computer Software Problem	3	3
Insufficient Heating	3	3
Failure to Analyze Signal	3	3
Noise, Audible	3	3
Communication or Transmission Problem	2	2
Connection Problem	2	2
Display or Visual Feedback Problem	2	2
Failure to Run on Battery	2	2
Fitting Problem	1	1
Fire	1	1
High impedance	1	1
Insufficient Information	1	1
Smoking	1	1
No Audible Prompt/Feedback	1	1
High Test Results	1	1
Defective Alarm	1	1
Protective Measures Problem	1	1
Image Orientation Incorrect	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	115	115
Insufficient Information	74	74
No Consequences Or Impact To Patient	7	7
No Patient Involvement	4	4
Awareness during Anaesthesia	4	4
Injury	3	3
Skin Inflammation/ Irritation	2	2
Oversedation	2	2
Pressure Sores	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
Rash	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1