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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output below Specifications	2781	2782
Insufficient Flow or Under Infusion	170	171
Infusion or Flow Problem	85	85
Improper Flow or Infusion	43	43
Inaccurate Delivery	25	25
Excess Flow or Over-Infusion	20	20
Unexpected Therapeutic Results	19	19
No Apparent Adverse Event	11	11
Detachment of Device or Device Component	10	10
Output above Specifications	10	10
Low Readings	9	9
Therapeutic or Diagnostic Output Failure	7	7
Gas Output Problem	6	6
Insufficient Information	4	4
Use of Device Problem	3	3
Gas/Air Leak	3	3
No Flow	3	3
Leak/Splash	3	3
High Readings	2	2
Electrical Overstress	2	2
Device Handling Problem	2	2
Defective Device	2	2
Overheating of Device	2	2
No Display/Image	2	2
Fluid/Blood Leak	2	2
Deflation Problem	1	1
Defective Component	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inflation 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
Connection Problem	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Run on Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3133	3135
Insufficient Information	5	5
Oversedation	4	4
Low Blood Pressure/ Hypotension	4	4
Awareness during Anaesthesia	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Fecal Incontinence	2	2
Syncope/Fainting	1	1
High Blood Pressure/ Hypertension	1	1
Dizziness	1	1
Chemical Exposure	1	1
Paresthesia	1	1
Convulsion/Seizure	1	1
Inadequate Pain Relief	1	1
Low Oxygen Saturation	1	1