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	49	51
Insufficient Flow or Under Infusion	40	40
Inaccurate Delivery	19	19
Unexpected Therapeutic Results	18	18
Excess Flow or Over-Infusion	9	9
Low Readings	7	7
Mechanical Problem	5	5
Gas/Air Leak	4	4
Gas Output Problem	4	4
Improper Flow or Infusion	3	3
Insufficient Information	3	3
No Display/Image	2	2
Electrical Overstress	2	2
Defective Device	2	2
Failure to Deliver	2	2
Device Handling Problem	2	2
No Flow	2	2
Detachment of Device or Device Component	2	2
Overheating of Device	2	2
Fluid/Blood Leak	2	2
Leak/Splash	1	1
Application Program Problem: Medication Error	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Restricted Flow rate	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inaccurate Flow Rate	1	1
No Apparent Adverse Event	1	1
Activation Failure	1	1
Defective Alarm	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Connection Problem	1	1
Output below Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	148	148
No Consequences Or Impact To Patient	8	8
No Known Impact Or Consequence To Patient	5	7
Awareness during Anaesthesia	5	5
Insufficient Information	4	4
High Blood Pressure/ Hypertension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Patient Involvement	2	2
Low Blood Pressure/ Hypotension	2	2
Syncope/Fainting	1	1
No Code Available	1	1
Dizziness	1	1
Chemical Exposure	1	1
Cardiac Arrest	1	1
Paresthesia	1	1
Pain	1	1
Shock, Traumatic	1	1
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1