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	114	114
High Readings	37	38
Temperature Problem	37	37
Device Damaged Prior to Use	23	23
Device Alarm System	18	18
Image Display Error/Artifact	18	18
Low Readings	18	18
Material Split, Cut or Torn	11	11
Increase in Pressure	10	10
Use of Device Problem	8	8
Communication or Transmission Problem	7	7
Failure to Power Up	7	7
Patient Device Interaction Problem	6	8
Failure to Run on Battery	5	5
No Apparent Adverse Event	4	4
Display or Visual Feedback Problem	4	4
Defective Component	3	3
Unable to Obtain Readings	3	3
Data Problem	3	3
Computer Software Problem	3	3
Erratic or Intermittent Display	3	3
Insufficient Heating	3	3
Failure to Analyze Signal	3	3
Noise, Audible	3	3
Connection Problem	2	2
Fitting Problem	1	1
Fire	1	1
High impedance	1	1
Insufficient Information	1	1
Smoking	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Component Missing	1	1
No Audible Prompt/Feedback	1	1
High Test Results	1	1
Defective Alarm	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	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	146	146
Insufficient Information	90	91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Awareness during Anaesthesia	5	5
Skin Inflammation/ Irritation	2	4
Oversedation	2	2
Pressure Sores	2	2
Cardiac Arrest	1	1
Rash	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1