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
Insufficient Information	3	3
Improper Flow or Infusion	3	3
Device Handling Problem	2	2
Detachment of Device or Device Component	2	2
No Display/Image	2	2
Defective Device	2	2
Electrical Overstress	2	2
Failure to Deliver	2	2
Overheating of Device	2	2
Fluid/Blood Leak	2	2
No Flow	2	2
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	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
Leak/Splash	1	1
Restricted Flow rate	1	1
Use of Device Problem	1	1
Application Program Problem: Medication Error	1	1
Failure to Align	1	1
Output below Specifications	1	1
Connection Problem	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	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