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	9	9
Use of Device Problem	7	7
Fail-Safe Did Not Operate	5	5
Key or Button Unresponsive/not Working	4	4
Protective Measures Problem	4	4
Failure to Align	3	3
Insufficient Device Problem Information	3	3
Decrease in Pressure	3	3
No Apparent Adverse Event	3	3
Pressure Problem	2	2
Mechanical Problem	2	2
Fail-Safe Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	1	1
Activation Problem	1	1
Emergency Power Failure	1	1
Complete Blockage	1	1
Contamination /Decontamination Problem	1	1
Patient Device Interaction Problem	1	1
Sharp Edges	1	1
Use of Incorrect Control/Treatment Settings	1	1
Increase in Pressure	1	1
Device Reprocessing Problem	1	1
Gradient Increase	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
Insufficient Information	6	6
Ear Pain	6	6
Convulsion/Seizure	5	5
Cramp(s) /Muscle Spasm(s)	2	2
Dyspnea	2	2
Unspecified Tissue Injury	2	2
Headache	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Superficial (First Degree) Burn	1	1
Total Hearing Loss	1	1
Pneumothorax	1	1
Memory Loss/Impairment	1	1
Inflammation	1	1
Malaise	1	1
Transient Ischemic Attack	1	1
Burn(s)	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Discomfort	1	1
Pain	1	1
Physical Entrapment	1	1
Blood Bicarbonate Increased	1	1
Abnormal mucus discharge	1	1
Partial thickness (Second Degree) Burn	1	1
Loss of consciousness	1	1
Neuralgia	1	1
Lethargy	1	1