TPLC - Total Product Life Cycle

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Device	vaporizer, anesthesia, non-heated
Product Code	CAD
Regulation Number	868.5880
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Infusion or Flow Problem	29	31
Insufficient Flow or Under Infusion	26	26
Unexpected Therapeutic Results	17	17
Inaccurate Delivery	13	13
Mechanical Problem	5	5
Gas/Air Leak	4	4
Improper Flow or Infusion	3	3
Insufficient Information	3	3
Gas Output Problem	3	3
Excess Flow or Over-Infusion	3	3
Overheating of Device	2	2
No Display/Image	2	2
Defective Device	2	2
Failure to Deliver	2	2
Device Handling Problem	2	2
Electrical Overstress	2	2
No Flow	2	2
Adverse Event Without Identified Device or Use Problem	1	1
No Apparent Adverse Event	1	1
Defective Alarm	1	1
Activation Failure	1	1
Appropriate Term/Code Not Available	1	1
Application Program Problem: Medication Error	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Low Readings	1	1
Failure to Align	1	1
Electrical /Electronic Property Problem	1	1
Restricted Flow rate	1	1
Inaccurate Flow Rate	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	92	92
No Consequences Or Impact To Patient	8	8
No Known Impact Or Consequence To Patient	5	7
Awareness during Anaesthesia	5	5
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
High Blood Pressure/ Hypertension	2	2
Low Blood Pressure/ Hypotension	2	2
No Patient Involvement	2	2
Pain	1	1
Dizziness	1	1
Shock, Traumatic	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1
Chemical Exposure	1	1
Cardiac Arrest	1	1
No Code Available	1	1
Convulsion/Seizure	1	1
Syncope/Fainting	1	1
Paresthesia	1	1