TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K240375 V80 Anesthetic Vaporizer (V80)

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output below Specifications	3086	3087
Insufficient Flow or Under Infusion	178	179
Infusion or Flow Problem	90	90
Improper Flow or Infusion	44	44
Inaccurate Delivery	26	26
Excess Flow or Over-Infusion	21	21
Output above Specifications	20	20
Unexpected Therapeutic Results	19	19
No Apparent Adverse Event	11	11
Detachment of Device or Device Component	10	10
Low Readings	9	9
Therapeutic or Diagnostic Output Failure	8	8
Gas Output Problem	6	6
Insufficient Information	4	4
Gas/Air Leak	4	4
No Flow	3	3
Device Handling Problem	3	3
Use of Device Problem	3	3
Mechanical Problem	3	3
Leak/Splash	3	3
High Readings	2	2
Electrical Overstress	2	2
Defective Device	2	2
Overheating of Device	2	2
No Display/Image	2	2
Fluid/Blood Leak	2	2
Failure to Run on Battery	2	2
Application Program Problem: Medication Error	1	1
Deflation Problem	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inflation Problem	1	1
Defective Component	1	1
Device Sensing Problem	1	1
Unintended Movement	1	1
Activation Failure	1	1
Energy Output Problem	1	1
Fracture	1	1
Perivalvular Leak	1	1
Appropriate Term/Code Not Available	1	1
Restricted Flow rate	1	1
Intermittent Continuity	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	3463	3465
Insufficient Information	6	6
Awareness during Anaesthesia	5	5
Oversedation	4	4
No Consequences Or Impact To Patient	4	4
Low Blood Pressure/ Hypotension	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Fecal Incontinence	2	2
High Blood Pressure/ Hypertension	1	1
Syncope/Fainting	1	1
Dizziness	1	1
Chemical Exposure	1	1
Paresthesia	1	1
No Patient Involvement	1	1
Pain	1	1
Shock, Traumatic	1	1
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1