TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Use of Device Problem	5	5
Mechanical Problem	3	3
Insufficient Information	3	3
Fail-Safe Did Not Operate	3	3
Key or Button Unresponsive/not Working	3	3
Decrease in Pressure	3	3
No Apparent Adverse Event	3	3
Fail-Safe Problem	2	2
Failure to Align	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	1	1
Pressure Problem	1	1
Emergency Power Failure	1	1
Complete Blockage	1	1
Contamination /Decontamination Problem	1	1
Sharp Edges	1	1
Product Quality Problem	1	1
Increase in Pressure	1	1
Protective Measures Problem	1	1
Unexpected Therapeutic Results	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	31	31
Convulsion/Seizure	5	5
Insufficient Information	4	4
Death	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Dyspnea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Total Hearing Loss	1	1
Superficial (First Degree) Burn	1	1
Pneumothorax	1	1
Memory Loss/Impairment	1	1
Transient Ischemic Attack	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Cardiopulmonary Arrest	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Low Oxygen Saturation	1	1
Neuralgia	1	1