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	79	79
High Readings	31	31
Temperature Problem	29	29
Device Damaged Prior to Use	19	19
Low Readings	17	17
Image Display Error/Artifact	13	13
Increase in Pressure	10	10
Material Split, Cut or Torn	9	9
Device Alarm System	9	9
Patient Device Interaction Problem	6	6
Use of Device Problem	5	5
No Apparent Adverse Event	4	4
Erratic or Intermittent Display	4	4
Appropriate Term/Code Not Available	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
Failure to Power Up	2	2
Connection 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
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	109	109
Insufficient Information	68	68
Awareness during Anaesthesia	4	4
No Consequences Or Impact To Patient	4	4
No Patient Involvement	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
Injury	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1